Navelbine 80mg Soft Capsule

1. Name Of The Medicinal Product

NAVELBINE® 80 mg soft capsule

2. Qualitative And Quantitative Composition

Each soft capsule contains 80mg vinorelbine as tartrate

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Soft capsule.

Pale yellow soft capsule printed N80.

4. Clinical Particulars

4.1 Therapeutic Indications

As a single agent or in combination for:

• The first line treatment of stage 3 or 4 non small cell lung cancer.

• The treatment of advanced breast cancer stage 3 and 4 relapsing after or refractory to an anthracycline containing regimen.

4.2 Posology And Method Of Administration

In adult patients

As a single agent, the recommended regimen is:

First three administrations

60mg/m² of body surface area, administered once weekly

Subsequent administrations

Beyond the third administration, it is recommended to increase the dose of Navelbine to 80mg/m² once weekly except in those patients for whom the neutrophil count dropped once below 500/mm³ or more than once between 500 and 1000/mm³ during the first three administrations at 60mg/m².

Neutrophil count during the first 3 administrations of 60 mg/m2/week	Neutrophils > 1000	Neutrophils (1 episode)	Neutrophils (2 episodes)	Neutrophils < 500
Recommended dose starting with the 4th administration	80	80	60	60

Dose modification

For any administration planned to be given at 80mg/m², if the neutrophil count is below 500/mm³ or more than once between 500 and 1000 / mm³ the administration should be delayed until recovery and the dose reduced from 80 to 60mg/m² per week during the 3 following administrations.

If the neutrophil count is below 1500 /mm³ and/or the platelet count below 100000/mm³, then the treatment should be delayed until recovery.

Neutrophil countbeyond the 4th administration of 80 mg/m2/week	Neutrophils > 1000	Neutrophils (1 episode)	Neutrophils (2 episodes)	Neutrophils < 500
Recommended dose starting with the next administration	80	60

It is possible to re-escalate the dose from 60 to 80 mg/m² per week if the neutrophil count did not drop below 500/mm³ or more than once between 500 and 1000/mm³ during 3 administrations given at 60 mg/m² according to the rules previously defined for the first 3 administrations.

For combination regimens, the dose and schedule will be adapted to the treatment protocol.

Based on clinical studies, the oral dose of 80 mg/m² was demonstrated to correspond to 30 mg/m² of the iv form and 60 mg/m² to 25 mg/m².

This has been the base for combination regimens alternating iv and oral forms improving patient convenience.

Capsules of different strengths (20, 30, 80 mg) are available in order to choose the adequate combination for the right dosage.

The following table gives the dose required for appropriate ranges of body surface area (BSA).

	60 mg/m2	80 mg/m2
BSA (m2)	Dose (mg)	Dose (mg)
0.95 to 1.04 1.05 to 1.14 1.15 to 1.24 1.25 to 1.34 1.35 to 1.44 1.45 to 1.54 1.55 to 1.64 1.65 to 1.74 1.75 to 1.84 1.85 to 1.94	60 70 70 80 80 90 100 100 110 110 120	80 90 100 100 110 120 130 140 140 150 160

Even for patients with BSA > 2 m2 the total dose should never exceed 120 mg per week at 60 mg /m2 and 160 mg per week at 80 mg/m2.

Administration

Navelbine must be given strictly by the oral route.

Navelbine must be swallowed whole with water, without chewing, sucking or dissolving the capsule.

It is recommended to administer the capsule with some food.

Administration in the elderly

Clinical experience has not detected any significant differences among elderly patients with regard to the response rate, although greater sensitivity in some of these patients cannot be excluded. Age does not modify the pharmacokinetics of vinorelbine: see section 5.2.

Administration in children

Safety and efficacy in children have not been established and administration is therefore not recommended.

Administration in patients with liver insufficiency

Navelbine can be administered at the standard dose of 60 mg/m²/week in patients with mild liver impairment (bilirubin < 1.5 x ULN, and ALAT and/or ASAT from 1.5 to 2.5 x ULN). In patients with moderate liver impairment (bilirubin from 1.5 to 3 x ULN, whatever the levels of ALAT and ASAT), Navelbine should be administered at a dose of 50 mg/m²/week. The administration of Navelbine in patients with severe hepatic impairment is contra-indicated: see sections 4.3, 4.4, 5.2.

Administration in patients with renal insufficiency

Given the minor renal excretion, there is no pharmacokinetic justification for reducing the dose of Navelbine in patients with serious renal insufficiency: see sections 4.4, 5.2.

Specific instructions must be observed for handling Navelbine: see section 6.6

4.3 Contraindications

- Known hypersensitivity to vinorelbine or other vinca-alkaloids or to any of the constituents.

- Disease significantly affecting absorption

- Previous significant surgical resection of stomach or small bowel.

- Neutrophil count < 1500/mm³ or severe infection current or recent (within 2 weeks).

- Platelet count < 100000/mm³

- Severe hepatic insufficiency

- Pregnancy: see section 4.6

- Lactation: see section 4.6

- Patients requiring long-term oxygen therapy

- In combination with yellow fever vaccine: see section 4.5

4.4 Special Warnings And Precautions For Use

Special warnings

Navelbine should be prescribed by a physician who is experienced in the use of chemotherapy with facilities for monitoring cytotoxic drugs.

If the patient chews or sucks the capsule by error, the liquid is an irritant. Proceed to mouth rinses with water or preferably a normal saline solution.

In the event of the capsule being cut or damaged, the liquid content is an irritant, and so may cause damage if in contact with skin, mucosa or eyes. Damaged capsules should not be swallowed and should be returned to the pharmacy or to the doctor in order to be properly destroyed. If any contact occurs, immediate thorough washing with water or preferably with normal saline solution should be undertaken.

In the case of vomiting within a few hours after drug intake, do not re-administer. Supportive treatment such as metoclopramide or 5HT₃ antagonists (e.g. ondansetron, granisetron) may reduce the occurrence of this: see section 4.5. Navelbine soft capsule is associated with a higher incidence of nausea/vomiting than the intravenous formulation. Primary prophylaxis with antiemetics and administration of the capsules with some food is recommended as this has also been shown to reduce the incidence of nausea and vomiting: see section 4.2.

Patients receiving concomitant morphine or opioid analgesics: laxatives and careful monitoring of bowel mobility are recommended. Prescription of laxatives may be appropriate in patients with prior history of constipation.

Due to sorbitol content, patients with rare hereditary problems with fructose intolerance should not take the capsules.

Close haematological monitoring must be undertaken during treatment (determination of haemoglobin level and the leucocyte, neutrophil and platelet counts on the day of each new administration).

Dosing should be determined by haematological status:

- If the neutrophil count is below 1500 /mm³ and/or the platelet count is below 100000/mm³, then the treatment should be delayed until recovery.

- For dose escalation from 60 to 80 mg/m² per week, after the third administration: see section 4.2.

- For the administrations given at 80mg/m², if the neutrophil count is below 500/mm³ or more than once between 500 and 1000 /mm³, then the treatment should be delayed until recovery. The administration should not only be delayed but also reduced to 60mg/m² per week. It is possible to reescalate the dose from 60 to 80 mg/m² per week: see section 4.2.

During clinical trials where treatments were initiated at 80 mg/m², a few patients developed excessive neutropenic complications including those with a poor performance status. Therefore it is recommended that the starting dose should be 60 mg/m² escalating to 80 mg/m² if the dose is tolerated as described in section 4.2.

If patients present signs or symptoms suggestive of infection, a prompt investigation should be carried out.

Special precautions for use

Special care should be taken when prescribing for patients with:

- history of ischemic heart disease: see section 4.8

- poor performance status

Navelbine should not be given concomitantly with radiotherapy if the treatment field includes the liver.

This product is specifically contra-indicated with yellow fever vaccine and its concomitant use with other live attenuated vaccines is not recommended: see section 4.3.

Caution must be exercised when combining Navelbine and strong inhibitors or inducers of CYP3A4 (see section 4.5), and its combination with phenytoin (like all cytotoxics) and with itraconazole (like all vinca alkaloids) is not recommended.

Oral Navelbine was studied in patients with liver impairment at the following doses:

- 60 mg/m² in 7 patients with mild liver impairment (bilirubin < 1.5 x ULN, and ALAT and/or ASAT from 1.5 to 2.5 x ULN);

- 50 mg/m² in 6 patients with moderate liver impairment (bilirubin from 1.5 to 3 x ULN, whatever the levels of ALAT and ASAT).

Total clearance of vinorelbine was neither modified between mild and moderate liver impairment nor was it altered in hepatically impaired patients when compared with clearance in patients with normal liver function.

Oral Navelbine was not studied in patients with severe hepatic impairment therefore its use is contra-indicated in these patients: see sections 4.2, 4.3, 5.2.

As there is a low level of renal excretion there is no pharmacokinetic rationale for reducing the dose of Navelbine in patients with impaired kidney function: see sections 4.2, 5.2.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use contraindicated

Yellow fever vaccine: as with all cytotoxics, risk of fatal generalised vaccine disease: see section 4.3.

Concomitant use not recommended

Live attenuated vaccines: (for yellow fever vaccine, see concomitant use contraindicated) as with all cytotoxics, risk of generalised vaccine disease, possibly fatal. This risk is increased in patients already immunodepressed by their underlying disease. It is recommended to use an inactivated vaccine when one exists (e.g. poliomyelitis): see section 4.4

Phenytoin: as with all cytotoxics, risk of exacerbation of convulsions resulting from the decrease of phenytoin digestive absorption by cytotoxic drug or risk of toxicity enhancement or loss of efficacy of the cytotoxic drug due to increased hepatic metabolism by phenytoin.

Itraconazole: as with all vinca-alkaloids, increased neurotoxicity of vinca-alkaloids due to the decrease of their hepatic metabolism.

Concomitant use to take into consideration

Cisplatin: There is no mutual pharmacokinetic interaction when combining Navelbine with cisplatin over several cycles of treatment. However, the incidence of granulocytopenia associated with Navelbine use in combination with cisplatin is higher than associated with Navelbine single agent.

Mitomycin C: risk of bronchospasm and dyspnoea are increased, in rare case an interstitial pneumonitis was observed.

Ciclosporin, tacrolimus: excessive immunodepression with risk of lymphoproliferation.

As vinca-alkaloids are known as substrates for P-glycoprotein, and in the absence of specific study, caution should be exercised when combining Navelbine with strong modulators of this membrane transporter.

The combination of NAVELBINE with other drugs with known bone marrow toxicity is likely to exacerbate the myelosuppressive adverse effects.

No clinically significant pharmacokinetic interaction was observed when combining Navelbine with several other chemotherapeutic agents (paclitaxel, docetaxel, capecitabine and oral cyclophosphamide).

As CYP3A4 is mainly involved in the metabolism of vinorelbine, combination with strong inhibitors of this isoenzyme (e.g. azole antifungals such as ketoconazole and itraconazole) could increase blood concentrations of vinorelbine and combination with strong inducers of this isoenzyme (e.g. rifampicin, phenytoin) could decrease blood concentrations of vinorelbine.

Anti-emetic drugs such as 5HT₃ antagonists (e.g. ondansetron, granisetron) do not modify the pharmacokinetics of Navelbine soft capsules (see section 4.4).

Anticoagulant treatment: as with all cytotoxics, the frequency of INR (International Normalised Ratio) monitoring should be increased due to the potential interaction with oral anticoagulants and increased variability of coagulation in patients with cancer.

Food does not modify the pharmacokinetics of vinorelbine.

4.6 Pregnancy And Lactation

Pregnancy

Navelbine is suspected to cause serious birth effects when administered during pregnancy: see section 5.3.

Navelbine is contra-indicated in pregnancy: see section 4.3.

In case of a vital indication for treatment with Navelbine during pregnancy a medical consultation concerning the risk of harmful effects for the child should be conducted. If pregnancy occurs during treatment genetic counseling should be offered.

Women of child-bearing potential

Women of child-bearing potential must use effective contraception during treatment and up to 3 months after treatment: see section 4.3

Lactation

It is unknown whether vinorelbine is excreted in human breast milk.

The excretion of vinorelbine in milk has not been studied in animal studies.

A risk to the suckling child cannot be excluded therefore breast feeding must be discontinued before starting treatment with Navelbine: see section 4.3.

Fertility

Men being treated with Navelbine are advised not to father a child during and minimally up to 3 months after treatment: see section 4.3.

Prior to treatment advice should be sought for conserving sperm due to the chance of irreversible infertility as a consequence of treatment with vinorelbine.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed but on the basis of the pharmacodynamic profile vinorelbine does not affect the ability to drive and use machines. However, caution is necessary in patients treated with vinorelbine considering some adverse effects of the drug: see section 4.8.

4.8 Undesirable Effects

The overall reported frequency of undesirable effects was determined from clinical studies in 316 patients (132 patients with non small cell lung cancer and 184 patients with breast cancer) who received the recommended regimen of Navelbine (first three administrations at 60mg/m²/week followed by 80mg/m²/week).

Adverse reactions reported are listed below, by system organ and by frequency.

Additional Adverse reactions from Post Marketing experience has been added according to the MedDRA classification with the frequency Not known.

The reactions were described using the NCI common toxicity criteria

Very common
Common
Uncommon
Rare
Very rare	<1/10,000
Not known	Post marketing reports

Undesirable effects reported with Navelbine soft capsule:

Pre-marketing experience:

The most commonly reported adverse drug reactions are bone marrow depression with neutropenia, anaemia and thrombocytopenia, gastrointestinal toxicity with nausea, vomiting, diarrhoea, stomatitis and constipation. Fatigue and fever were also reported very commonly.

Post-marketing experience:

Navelbine soft capsule is used as single agent or in combination with other chemotherapeutic agents or targeted therapy agents such as cisplatin, capecitabine, carboplatin, epirubicin, trastuzumab, erlotinib, sorafenib.

The most commonly system organ classes involved during post-marketing experience are: 'Blood and lymphatic system disorders', 'Gastrointestinal disorders', 'Infections and infestations' and 'General disorders and administration site conditions'. This information is consistent with the pre-marketing experience.

Infections and infestations
Very common:	Bacterial, viral or fungal infections without neutropenia at different sites: G1-4: 12.7%; G3-4: 4.4%,
Common:	Bacterial, viral or fungal infections resulting from bone marrow depression and/or immune system compromise (neutropenic infections) are usually reversible with an appropriate treatment. Neutropenic infection: G3-4: 3.5%.
Not known:	Neutropenic sepsis.

Blood and lymphatic disorders
Very common:	Bone marrow depression resulting mainly in neutropenia G1-4: 71.5%; G3: 21.8%; G4: 25.9%, is reversible and is the dose limiting toxicity. Leucopenia: G1-4: 70.6 %; G3: 24.7 %; G4: 6%. Anaemia: G1-4: 67.4 %; G3-4: 3.8%. Thrombocytopenia: G1-2: 10.8%.
Common:	G4 Neutropenia associated with fever over 38°C including febrile neutropenia 2.8%.

Metabolism and nutrition disorders
Not known:	Severe hyponatraemia.

Psychiatric disorders
Common:	Insomnia : G1-2: 2.8%.

Nervous system disorders
Very common:	Neurosensory disorders: G1-2: 11.1%, generally limited to loss of tendon reflexes and infrequently severe.
Common:	Neuromotor disorders: G1-4: 9.2%; G3-4:1.3%. Headache: G1-4: 4.1%, G3-4: 0.6%. Dizziness: G1-4: 6%; G3-4: 0.6%. Taste disorders: G1-2:3.8%.
Uncommon:	Ataxia grade 3: 0.3%.

Eye disorders
Common:	Visual disorders: G1-2: 1.3%.

Cardiac disorders
Not known:	Myocardial infarction in patients with cardiac medical history or cardiac risk factors.

Vascular disorders
Common:	Hypertension: G1-4: 2.5%; G3-4: 0.3%. Hypotension: G1-4: 2.2%; G3-4: 0.6%.

Respiratory system, thoracic and mediastinal disorders
Common:	Dyspnoea: G1-4: 2.8%; G3-4: 0.3%. Cough: G1-2: 2.8%.

Gastrointestinal disorders
Very Common:	Nausea: G1-4: 74.7% ; G3-4: 7.3%; Vomiting: G1-4: 54.7%; G 3-4: 6.3%, Supportive treatment such as 5HT3 antagonists (ondansetron) may reduce the occurrence of nausea and vomiting: see section 4.4. Diarrhoea: G1-4: 49.7%; G3-4: 5.7%, Anorexia: G 1-4: 38.6%; G 3-4: 4.1%, Stomatitis: G1-4:10.4%; G3-4: 0.9%, Abdominal pain: G1-4: 14.2%, Constipation: G1-4: 19%; G3-4: 0.9%, Prescription of laxatives may be appropriate in patients with prior history of constipation and/or who receive concomitant treatment with opioid analgesics: see section 4.4. Gastric disorders: G1-4: 11.7%.
Common:	Oesophagitis: G1-3: 3.8%; G3: 0.3%, Dysphagia: G1-2: 2.3%.
Uncommon:	Paralytic ileus: G3-4: 0.9% [rarely fatal], treatment may be resumed after recovery of normal bowel mobility.
Not known:	Gastro-intestinal bleeding.

Hepatobiliary disorders
Common:	Hepatic disorders: G1-2: 1.3%.

Skin and subcutaneous tissue disorders
Very common:	Alopecia usually mild in nature G1-2: 29.4%, may occur.
Common:	Skin reactions: G1-2: 5.7%.

Musculoskeletal and connective tissue disorders
Common:	Arthralgia including jaw pain, Myalgia: G1-4: 7 %, G3-4: 0.3%.

Renal and urinary disorders
Common:	Dysuria: G1-2: 1.6%. Other genitourinary disorders: G1-2: 1.9%.

General disorders and administration site conditions
Very common:	Fatigue/malaise: G1-4: 36.7%; G3-4: 8.5%. Fever: G1-4: 13.0%, G3-4: 12.1%.
Common:	Pain including pain at the tumour site: G1-4: 3.8%, G3-4: 0.6%. Chills: G1-2: 3.8%.

Investigations
Very common:	Weight loss: G1-4: 25%, G3-4: 0.3%.
Common:	Weight gain: G1-2: 1.3%.

Undesirable effects with Navelbine, concentrate for infusion:

Some undesirable effects were observed with Navelbine, concentrate for solution for infusion during pre- and post-marketing experience which were not reported with Navelbine soft capsule.

In order to provide the complete information and to further the safety of use of Navelbine soft capsule, these effects are presented below:

Infections and infestations
Uncommon:	Septicaemia [very rarely fatal]

Immune system disorders
Not known:	Systemic allergic reactions were reported as anaphylaxis, anaphylactic shock or anaphylactoïd type reaction.

Endocrine disorders
Not known:	Inappropriate antidiuretic hormone secretion (SIADH).

Vascular disorders
Uncommon:	Flushing and peripheral coldness
Rare:	Severe hypotension, collapse.

Respiratory system, thoracic and mediastinal disorders
Uncommon:	Bronchospasm may occur as with other vinca alkaloids.
Rare:	Interstitial pneumonopathy has been reported in particular in patients treated with Navelbine in combination with mitomycin.

Gastrointestinal disorders
Rare:	Pancreatitis.

4.9 Overdose

Symptoms

Overdosage with Navelbine soft capsules could produce bone marrow hypoplasia sometimes associated with infection, fever, paralytic ileus and hepatic disorders.

Emergency procedure

General supportive measures together with blood transfusion, growth factors, and broad spectrum antibiotic therapy should be instituted as deemed necessary by the physician. A close monitoring of hepatic function recommended.

Antidote

There is no known antidote for overdosage of Navelbine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Vinca alkaloïds and analogues (ATC Code: L01C A04)

Navelbine is a antineoplastic drug of the vinca alkaloid family but unlike all the other vinca alkaloids, the catharantine moiety of vinorelbine has been structurally modified. At the molecular level, it acts on the dynamic equilibrium of tubulin in the microtubular apparatus of the cell. It inhibits tubulin polymerization and binds preferentially to mitotic microtubules, affecting axonal microtubules at high concentrations only. The induction of tubulin spiralization is less than that produced by vincristine.

Navelbine blocks mitosis at G2-M, causing cell death in interphase or at the following mitosis.

Safety and efficacy of Navelbine in paediatric patients have not been established. Clinical data from two single-arm Phase II studies using intravenous vinorelbine in 33 and 46 paediatric patients with recurrent solid tumours, including rhabdomyosarcoma, other soft tissue sarcoma, Ewing sarcoma, liposarcoma, synovial sarcoma, fibrosarcoma, central nervous system cancer, osteosarcoma, neuroblastoma at doses of 30 to 33.75mg/m² D1 and D8 every 3 weeks or once weekly for 6 weeks every 8 weeks showed no meaningful clinical activity. The toxicity profile was similar to that reported in adult patients (see section 4.2).

5.2 Pharmacokinetic Properties

Pharmacokinetic parameters of vinorelbine were evaluated in blood.

Absorption

After oral administration, vinorelbine is rapidly absorbed and the T_max is reached between 1.5 to 3 h with a blood concentration peak (C_max) of approximately 130 ng/ml after a dose of 80 mg/m².

Absolute bioavailability is approximately 40% and a simultaneous intake of food does not alter the exposure to vinorelbine.

Oral vinorelbine at 60 and 80 mg/m² leads to blood exposure comparable to that achieved with intravenous vinorelbine at 25 and 30 mg/m², respectively.

The blood exposure to vinorelbine increases proportionally with the dose up to 100mg/m². Interindividual variability of the exposure is similar after administration by intravenous and oral routes.

Distribution

The steady-state volume of distribution is large, on average 21.2 l.kg^-1(range: 7.5 - 39.7 l.kg^-1), which indicates extensive tissue distribution.

Binding to plasma proteins is weak (13.5%), vinorelbine binds strongly to blood cells and especially to platelets (78%).

There is a significant uptake of vinorelbine in lungs, as assessed by pulmonary surgical biopsies which showed concentration up to a 300- fold higher concentration than in serum. Vinorelbine is not found in the central nervous system.

Biotransformation

All metabolites of vinorelbine are formed by CYP3A4 isoform of cytochromes P450, except 4-O-deacetylvinorelbine likely to be formed by carboxylesterases. 4-O-deacetylvinorelbine is the only active metabolite and the main one observed in blood.

Neither sulfate nor glucuronide conjugates are found.

Elimination

The mean terminal half-life of vinorelbine is around 40 hours. Blood clearance is high, approaching hepatic blood flow, and is 0.72 l.h^-1.kg^-1 (range: 0.32-1.26 l.h^-1.kg^-1).

Renal elimination is low (<5 % of the dose administered) and consists mostly in parent compound. Biliary excretion is the predominant elimination route of both unchanged vinorelbine, which is the main recovered compound, and its metabolites.

Special patients groups

Renal and liver impairment:

The effects of renal dysfunction on the pharmacokinetics of vinorelbine have not been studied. However, dose reduction in case of reduced renal function is not indicated with vinorelbine due to the low level of renal elimination.

Pharmacokinetics of orally administered vinorelbine were not modified after administration of 60 mg/m² in 7 patients with mild liver impairment (bilirubin < 1.5 x ULN, and ALAT and/or ASAT from 1.5 to 2.5 x ULN) and of 50 mg/m² in 6 patients with moderate liver impairment (bilirubin from 1.5 to 3 x ULN, whatever the levels of ALAT and ASAT). Total clearance of vinorelbine was neither modified between mild and moderate impairment nor was it altered in hepatically impaired patients when compared with clearance in patients with normal liver function.

No data is available for patients with severe liver impairment therefore Navelbine is contra-indicated in these patients: see sections 4.2, 4.3 and 4.4.

Elderly patients

A study with oral vinorelbine in elderly patients (

Pharmacokinetics/Pharmacodynamic relationships

A strong relationship has been demonstrated between blood exposure and depletion of leucocytes or PMNs.

5.3 Preclinical Safety Data

Pre-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.

Vinorelbine induced chromosome changes but was not mutagenic in Ames test. It is assumed that vinorelbine can cause mutagenic effects (induction of aneuploidy of polyploidy) in man.

In animal reproductive studies, vinorelbine was embryo-feto-lethal and teratogenic.

No haemodynamic effects were found in dogs receiving vinorelbine at maximal tolerated dose; only some minor, non significant disturbances of repolarisation were observed as with other vinca alkaloids tested.

No effect on the cardiovascular system was observed in primates receiving repeated doses of vinorelbine over 39 weeks.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Fill solution:

Ethanol, anhydrous

Water, purified

Glycerol

Macrogol 400

Shell capsule:

Gelatin

Glycerol 85%

Sorbitol/Sorbitan Anidrisorb 85/70)

Yellow iron oxide E172

Titanium dioxide E171

Triglycerides, medium chain

Phosal 53 MCT (Phosphatidylcholine; Glycerides; Ethanol, anhydrous)

Edible printing ink:

Cochineal extract E120

Hypromellose

Propylene glycol

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store at 2° C - 8° C (in a refrigerator). Store in the original container.

6.5 Nature And Contents Of Container

Peel-push PVC/PVDC/ aluminium blister.

Pack size: 1 capsule

Guiatex PE

guaifenesin and phenylephrine hydrochloride
Guiatex PE™ Syrup

Guiatex PE Description

Each teaspoonful (5 mL) of Guiatex PE™ Syrup contains:

Guaifenesin	200 mg
Phenylephrine Hydrochloride	5 mg

INACTIVE INGREDIENTS

Sodium Benzoate, Citric Acid, Saccharin Sodium, Propylene Glycol, Polyethylene Glycol, Sorbitol Solution, Sucralose, D&C Red No. 33, FD&C Red No. 40, Strawberry Flavor, Purified Water.

Guaifenesin is an expectorant with the chemical name: 1,2-Propanediol, 3-(2-methoxyphenoxy)-,(±)-. Its structure is as follows:

C10H14O4                                                  M.W. 198.22

Phenylephrine Hydrochloride is a decongestant, having the chemical name (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride. Its structure is as follows:

C9H13NO2 • HCl                                             M.W. 203.67

Guiatex PE - Clinical Pharmacology

Guaifenesin

Guaifenesin is an expectorant which increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions. By reducing the viscosity of secretions, guaifenesin increases the efficiency of the cough reflex and of ciliary action in removing accumulated secretions from the trachea and bronchi. Guaifenesin is readily absorbed from the gastrointestinal tract and is rapidly metabolized and excreted in the urine. Guaifenesin has a plasma half-life of one hour. The major urinary metabolite is (α)-(2-methoxyphenoxy) lactic acid.

Phenylephrine Hydrochloride

Phenylephrine hydrochloride is a sympathomimetic amine which acts predominantly by a direct action on alpha (α) adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta (β) adrenergic receptors of the heart. Clinically, phenylephrine shrinks swollen mucous membranes, reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway patency. In therapeutic doses the drug causes little, if any, central nervous system (CNS) stimulation.

Indications and Usage for Guiatex PE

This product is indicated for temporarily relieving symptoms of upper respiratory tract disorders such as hay fever; as well as for the temporary relief of coughs associated with respiratory tract infections and related conditions such as pharyngitis, bronchitis, and asthma, when these conditions are complicated by tenacious mucus and/or mucus plugs and congestion. This product is effective in a productive as well as nonproductive cough, but is of particular value in a dry, nonproductive cough which tends to injure the mucous membrane of the air passages.

Contraindications

This product is contraindicated in patients with hypersensitivity to guaifenesin or with hypersensitivity or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias. Patients known to be hypersensitive to other sympathomimetic amines may exhibit cross sensitivity with phenylephrine. Phenylephrine is contraindicated in patients with hypertension or ventricular tachycardia and should be employed only with extreme caution in elderly patients or in patients with hyperthyroidism, bradycardia, partial heart block, myocardial disease, or severe arteriosclerosis. Phenylephrine is contraindicated in patients on monoamine oxidase inhibitor (MAOI) therapy and for 14 days after stopping MAOI therapy (see Drug Interactions).

Warnings

Do not exceed recommended dosage. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Sympathomimetics may produce central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension.

Hypertensive crisis can occur with concurrent use of phenylephrine and MAO inhibitors (and for 14 days after stopping MAOI therapy), indomethacin, or with beta (β) blockers and methyldopa. If a Hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling. Before prescribing medication to suppress or modify a cough, it is important that the underlying cause of the cough is identified, that modification of the cough does not increase the risk of physical or physiological complications, and that appropriate therapy for the primary disease is instituted.

Precautions

Information for Patients

Patient consultation should include the following information regarding proper use of this medication:

• Do not take more medication than the amount recommended. Take medication with food, water, or milk to minimize gastric irritation.


• Do not take MAO inhibitors (or for 14 days after stopping MAOI therapy) while taking this medication.


• If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose; not doubling doses.


• This medication should be stored in a tight, light-resistant container at temperatures between 15°-30°C (59°-86°F).


• Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.


• Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Drug Interactions

Beta (β) adrenergic blockers and MAO inhibitors (or for 14 days after stopping MAOI therapy) may potentiate the pressor effect of phenylephrine. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias.

Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine, and veratrum alkaloids. Concurrent use of tricyclic antidepressants may antagonize the effects of phenylephrine. Use of other vasopressor drugs during halothane anesthesia may cause serious cardiac arrhythmias.

Drug/Laboratory Test Interactions

Guaifenesin may increase renal clearance for urate and thereby lower serum uric acid levels. Guaifenesin may produce an increase in urinary 5-hydroxyindoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of the drug should be discontinued 48 hours prior to the collection of urine specimens for such tests.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No data are available on the long-term potential of Carcinogenesis, Mutagenesis or Impairment of Fertility in animals or humans.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Use of this product by nursing mothers is not recommended because of the higher than usual risk for an infant from sympathomimetic amines.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established. Appropriate studies on the relationship of age to the effects of Guaifenesin have not been performed in the pediatric population.

Geriatric Use

Geriatric patients are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and death.

Adverse Reactions

Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. No serious side effects from guaifenesin have been reported.

Overdosage

This product is comprised of pharmacologically different components (phenylephrine and guaifenesin). Therefore, it is difficult to predict the exact manifestation of symptoms in a given individual. A description of symptoms which are likely to appear after ingestion of an excess of the individual components follows: Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitation, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, hallucinations, and delirium. Overdosage with guaifenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 gm/kg, produced no signs of toxicity.

Treatment of acute overdosage would probably be based upon treating the patient for the symptoms of overdosage of phenylephrine as follows: The treatment of overdosage should provide symptomatic and supportive care. If the amount ingested is considered dangerous or excessive, induce vomiting with ipecac syrup unless the patient is convulsing, comatose, or has lost the gag reflex, in which case perform gastric lavage using a large bore tube. If indicated, follow with activated charcoal and a saline cathartic.

Guiatex PE Dosage and Administration

Adults and children over 12 years of age: 1 to 2 teaspoonfuls (5 to 10 mL) every 4 to 6 hours, not to exceed 12 teaspoons in 24 hours. Children 6 to 12 years: 1/2 to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 6 teaspoons in 24 hours. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.). Shake well before using.

How is Guiatex PE Supplied

Guiatex PE™ Syrup is supplied as a sugar free, alcohol free, strawberry flavored liquid, in bottles of 16 fl.oz. (473 mL), NDC 51991-597-16.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx ONLY

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Manufactured by:

Tri-Med Laboratories, Inc.

Somerset, NJ 08873

Iss. 7/08

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge

Pharmaceutical, Inc.

NDC 51991-597-16

Guiatex PE™

Syrup

• Sugar Free


• Alcohol Free

Description: Each 5 mL (one teaspoonful) for oral

administration contains:

Guaifenesin                                              200 mg

Phenylephrine Hydrochloride                        5 mg

INACTIVE INGREDIENTS: Sodium Benzoate, Citric

Acid, Saccharin Sodium, Propylene Glycol,

Polyethylene Glycol, Sorbitol Solution, Sucralose,

D&C Red No. 33, FD&C Red No. 40, Strawberry

Flavor, Purified Water.

Rx Only

Net Contents:

16 fl. oz. (473 mL)

Guiatex PE  guaifenesin and phenylephrine hydrochloride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-597 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 200 mg  in 5 mL Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength sodium benzoate   citric acid monohydrate   saccharin sodium   propylene glycol   polyethylene glycol   sorbitol   sucralose   D&C Red No. 33   FD&C Red No. 40   water

Product Characteristics Color PINK (Clear) Score      Shape Size Flavor STRAWBERRY Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-597-16 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		09/10/2008	01/31/2012

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
TriMed Laboratories, Inc.		182050567	MANUFACTURE

Revised: 10/2010Breckenridge Pharmaceutical, Inc.

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Gentak Drops

Pronunciation: jen-ta-MYE-sin
Generic Name: Gentamicin
Brand Name: Examples include Gentasol and Gentak

Gentak Drops are used for:

Treating surface eye infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

Gentak Drops are a topical antibiotic. It works by slowing the growth of, or killing, sensitive bacteria.

Do NOT use Gentak Drops if:

• you are allergic to any ingredient in Gentak Drops

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gentak Drops:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Gentak Drops. Because little, if any, of Gentak Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Gentak Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gentak Drops:

Use Gentak Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Gentak Drops are for use in the eye. Avoid contact with other mucous membranes.


• Soft contact lenses may absorb a chemical in Gentak Drops. Do not wear contact lenses while you are using Gentak Drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.


• To use Gentak Drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.


• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.


• To clear up your infection completely, use Gentak Drops for the full course of treatment. Keep using it even if you feel better in a few days.


• Using Gentak Drops at the same times each day will help you to remember to use it.


• If you miss a dose of Gentak Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Gentak Drops.

Important safety information:

• Gentak Drops may cause blurred vision. Use Gentak Drops with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Gentak Drops may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Be sure to use Gentak Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Gentak Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Do not use Gentak Drops for future eye problems without checking with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gentak Drops while you are pregnant. If you are or will be breast-feeding while you use Gentak Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gentak Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bloodshot eye; burning or stinging of the eye.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); delayed healing of the cornea; hallucinations; redness, itching or swelling of the eyelids; ulcers of the cornea.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Gentak side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Gentak Drops:

Store Gentak Drops at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, light, and moisture. Do not freeze. Keep Gentak Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Gentak Drops, please talk with your doctor, pharmacist, or other health care provider.


• Gentak Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Gentak Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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gemtuzumab Intravenous

jem-TOOZ-oo-mab oh-zoe-ga-MYE-sin

Intravenous route(Powder for Solution)

Should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials. Severe myelosuppression occurs when gemtuzumab is used at recommended doses. Severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events have occurred with therapy. Some of these hypersensitivity reactions have been fatal. Patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome; physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/ microliters prior to administration of gemtuzumab. Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported with therapy. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD .

Commonly used brand name(s):

In the U.S.

• Mylotarg

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For gemtuzumab

Gemtuzumab injection is a monoclonal antibody that is used to treat a type of cancer called acute myeloid leukemia (AML) in patients 60 years of age or older. It is used when other cancer treatments have not worked very well for these patients. Gemtuzumab interferes with the growth of leukemia cells, which are then destroyed by the body.

gemtuzumab was to be administered only by or under the immediate supervision of your doctor.

Products containing gemtuzumab were withdrawn from the U.S. market by Pfizer Inc. on October 15, 2010.

Before Using gemtuzumab

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For gemtuzumab, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to gemtuzumab or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of gemtuzumab injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemtuzumab injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of gemtuzumab. Make sure you tell your doctor if you have any other medical problems, especially:

• Breathing problems or


• Hypotension (low blood pressure) or


• Kidney disease or


• Liver disease or


• Lung disease or


• Neutropenia (low white blood cell count) or


• Thrombocytopenia (low platelet count)—Use with caution. May make these conditions worse.

• Chickenpox, or recent exposure, or


• Herpes zoster (shingles)—Risk of severe infection affecting other parts of the body.

• High white blood cell counts or


• Stem-cell transplant, history of—Use with caution. May increase risk for more serious side effects.

• Infection—May decrease your body's ability to fight an infection.

Proper Use of gemtuzumab

Medicines used to treat cancer are very strong and can have many side effects. Before receiving gemtuzumab, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor while you are receiving gemtuzumab.

A doctor or nurse will give you gemtuzumab in a hospital or cancer treatment center. gemtuzumab is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for about 2 hours.

gemtuzumab consists of two doses, usually given 14 days apart. You may also receive a medicine to prevent allergic reactions (such as diphenhydramine, methylprednisolone, or Benadryl®) before you receive gemtuzumab.

Your doctor may want you to drink extra fluids so you will pass more urine while you are using gemtuzumab. This will keep your kidneys working well and help prevent kidney problems. Talk to your doctor if you have questions about this.

Precautions While Using gemtuzumab

It is very important that your doctor check your progress at regular visits to make sure gemtuzumab is working properly. Blood tests are needed to check for any unwanted effects.

Using gemtuzumab while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

While you are being treated with gemtuzumab, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Gemtuzumab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Gemtuzumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

gemtuzumab may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor or nurse right away if you have blue lips, fingernails, or skin; difficult or fast breathing; dizziness, fainting, or lightheadedness; fever or chills; rash; trouble breathing or swallowing; or any swelling of your hands, face, or mouth after receiving gemtuzumab.

Check with your doctor immediately if you have any symptoms of liver problems including skin and eyes turning yellow, dark brown-colored urine, right-sided abdominal or stomach pain, fever, or severe tiredness.

gemtuzumab may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount; joint pain, stiffness, or swelling; lower back, side, or stomach pain; a rapid weight gain; swelling of the feet or lower legs; or unusual tiredness or weakness.

gemtuzumab Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the stools or urine


• bluish color of the fingernails, lips, skin, palms, or nailbeds


• blurred vision


• burning or stinging of the skin


• chest pain


• chills


• confusion


• convulsions (seizures)


• cough or hoarseness


• cracked lips


• decrease or increase in urine


• diarrhea


• difficulty with swallowing


• dizziness


• dry mouth


• excessive sweating


• fainting


• fast or slow heartbeat


• fever


• flushed, dry skin


• fruit-like breath odor


• headache, sudden and severe


• heavy, nonmenstrual vaginal bleeding


• inability to speak


• increased thirst or hunger


• irregular heartbeat


• large, flat, blue, or purplish patches in the skin


• lightheadedness


• lower back, joint, or side pain


• loss of appetite


• mood changes


• muscle pain or cramps


• muscle trembling or twitching


• nausea or vomiting


• numbness or tingling in the hands, feet, or lips


• pain, difficulty, or burning while urinating


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• pale skin


• palpitations


• persistent bleeding or oozing from puncture sites, mouth, or nose


• pinpoint red spots on the skin


• pounding in the ears


• rapid, shallow breathing


• rapid weight gain


• red or purplish patches or spots on the skin


• severe or continuing dull nervousness


• shortness of breath


• slurred speech


• small red or purple spots on the skin


• sneezing


• sore throat


• sores, ulcers, or white spots on the lips, tongue, or inside the mouth


• stomachache


• sweating


• swelling or inflammation of the mouth, face, fingers, feet, or lower legs


• swollen glands


• temporary blindness


• tightness in the chest


• tingling of the hands or feet


• troubled breathing, exertional


• unexplained nosebleeds


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• weakness in the arm or leg on one side of the body, sudden and severe


• wheezing


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach


• belching


• difficulty with moving


• dry, red, hot, or irritated skin


• full or bloated feeling or pressure in the stomach


• heartburn


• indigestion


• lack or loss of strength


• muscle pain or stiffness


• pain, swelling, or redness in the joints


• runny, stuffy nose


• stomach discomfort upset


• swelling of the abdominal or stomach area


• trouble with sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: gemtuzumab Intravenous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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• Gemtuzumab Intravenous Side Effects (in more detail)
• Gemtuzumab Intravenous Use in Pregnancy & Breastfeeding
• Gemtuzumab Intravenous Drug Interactions
• Gemtuzumab Intravenous Support Group
• 0 Reviews for Gemtuzumab Intravenous - Add your own review/rating

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