BLEOMYCIN injection, powder, lyophilized, for solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BLEOMYCIN SULFATE (UNII: 7DP3NTV15T) (BLEOMYCIN - UNII:40S1VHN69B)
Available from:
Teva Parenteral Medicines, Inc.
INN (International Name):
BLEOMYCIN SULFATE
Composition:
BLEOMYCIN 15 [USP'U]
Administration route:
INTRAMUSCULAR
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Bleomycin for injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is poorer in patients with previously irradiated head and neck cancer. Hodgkin's Disease, non-Hodgkin's lymphoma. Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin for injection has also been shown to be useful in the management of: Bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. Bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.
Product summary:
Bleomycin for Injection USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. Bleomycin for Injection USP is supplied as follows: NDC Number 0703-3154-01 15 Units per Vial Individually packaged 0703-3155-01 30 Units per Vial Individually packaged Stability The sterile powder is stable under refrigeration 2° to 8°C (36° to 46°F) and should not be used after the expiration date is reached. Bleomycin for Injection USP should not be reconstituted or diluted with 5% dextrose injection or other dextrose containing diluents. When reconstituted in 5% dextrose injection and analyzed by HPLC, Bleomycin for Injection USP demonstrates a loss of A2 and B2 potency that does not occur when Bleomycin for Injection USP is reconstituted in 0.9% sodium chloride for injection, 0.9%, USP. Bleomycin for Injection USP is stable for 24 hours at room temperature in 0.9 % sodium chloride injection. Vial stoppers do not contain natural rubber latex.
Authorization status:
Abbreviated New Drug Application
Authorization number:
0703-3154-01, 0703-3155-01

BLEOMYCIN- bleomycin injection, powder, lyophilized, for solution

Teva Parenteral Medicines, Inc.

----------

BLEOMYCIN for Injection USP

3154

3155

Rx Only

WARNING

It is recommended that bleomycin for injection be administered under the supervision of a

qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate

management of therapy and complications is possible only when adequate diagnostic and treatment

facilities are readily available.

Pulmonary fibrosis is the most severe toxicity associated with bleomycin. The most frequent

presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Its occurrence is

higher in elderly patients and in those receiving greater than 400 units total dose, but pulmonary

toxicity has been observed in young patients and those treated with low doses.

A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and

wheezing has been reported in approximately 1% of lymphoma patients treated with bleomycin.

DESCRIPTION

Bleomycin for Injection USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of

Streptomyces verticillus. It is freely soluble in water. Bleomycin for Injection USP contains sterile

bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or sodium hydroxide

can be used, if necessary, to adjust pH.

Bleomycin for Injection USP may be given by the intramuscular, intravenous or subcutaneous routes.

Its chemical name is N’-[3-(dimethylsul-phonio)propyl]bleomycin-amide (bleomycin A ) and N’-[4-

(guaniodobutyl)]bleomycin-amide (bleomycin B ). (Main component: Bleomycin A , in which R is

[CH ] S+CH CH CH -)

The molecular formula of bleomycin A is C

H N O S and a calculated molecular weight of

1414. The molecular formula of bleomycin B is C

H N O S and a calculated molecular weight

of 1425. The structural formula of bleomycins A and B are shown below.

Note: A unit of bleomycin is equal to the formerly used milligram activity. The term milligram activity

is a misnomer and was changed to units to be more precise.

CLINICAL PHARMACOLOGY

Mechanism of Action

Although the exact mechanism of action of bleomycin is unknown, available evidence indicates that the

main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA

and protein synthesis.

Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro

and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis.

When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin acts

as a sclerosing agent.

Pharmacokinetics

Absorption

Bleomycin is rapidly absorbed following either intramuscular, subcutaneous, intraperitoneal, or

intrapleural administration reaching peak plasma concentrations in 30 to 60 minutes. Systemic

bioavailability of bleomycin is 100% and 70% following intramuscular and subcutaneous

administrations, respectively, and 45% following both intraperitoneal and intrapleural administrations,

compared to intravenous and bolus administration.

Following intramuscular doses of 1 to 10 units/m , both peak plasma concentration and AUC increased

in proportion with the increase of dose.

Following intravenous bolus administration of 30 units of bleomycin to one patient with a primary germ

cell tumor of the brain, a peak CSF level was 40% of the simultaneously-obtained plasma level and was

attained in 2 hours after drug administration. The area under the bleomycin CSF concentration x time

curve was 25% of the area of the bleomycin plasma concentration x time curve.

Distribution

Bleomycin is widely distributed throughout the body with a mean volume of distribution of 17.5 L/m in

patients following a 15 units/m intravenous bolus dose. Protein binding of bleomycin has not been

studied.

Metabolism

Bleomycin is inactivated by a cytosolic cysteine proteinase enzyme, bleomycin hydrolase. The enzyme

is widely distributed in normal tissues with the exception of the skin and lungs, both targets of

bleomycin toxicity. Systemic elimination of the drug by enzymatic degradation is probably only

important in patients with severely compromised renal function.

Excretion

The primary route of elimination is via the kidneys. About 65% of the administered intravenous dose is

excreted in urine within 24 hours. In patients with normal renal function, plasma concentrations of

bleomycin decline biexponentially with a mean terminal half-life of 2 hours following intravenous bolus

administration. Total body clearance and renal clearance averaged 51 mL/min/m and 23 mL/min/m ,

respectively.

Following intrapleural administration to patients with normal renal function, a lower percentage of drug

(40%) is recovered in the urine, as compared to that found in the urine after intravenous administration.

Special Populations

Age, Gender, and Race

The effects of age, gender, and race on the pharmacokinetics of bleomycin have not been evaluated.

Pediatric

Children of less than 3 years of age have higher total body clearance than in adults, 71 mL/min/m

versus 51 mL/min/m , respectively, following intravenous bolus administration. Children of more than 8

years of age have comparable clearance as in adults.

In children with normal renal function, plasma concentrations of bleomycin decline biexponentially as in

adults. The volume of distribution and terminal half-life of bleomycin in children appears comparable to

that in adults.

Renal Insufficiency

Renal insufficiency markedly alters bleomycin elimination. The terminal elimination half-life increases

exponentially as the creatinine clearance decreases. Dosing reductions were proposed for patients with

creatinine clearance values of < 50 mL/min (see PRECAUTIONS and DOSAGE AND

ADMINISTRATION).

Hepatic Insufficiency

The effect of hepatic insufficiency on the pharmacokinetics of bleomycin has not been evaluated.

Drug Interactions

Drugs that Can Affect Renal Clearance

Because bleomycin is eliminated predominantly through renal excretion, the administration of

nephrotoxic drugs with bleomycin may affect its renal clearance. Specifically, in one report of 2

children receiving concomitant cisplatin with bleomycin, total body clearance of bleomycin decreased

from 39 to 18 mL/min/m as the cumulative dose of cisplatin exceeded 300 mg/m . Terminal half-life of

bleomycin also increased from 4.4 to 6 hours. Fatal bleomycin pulmonary toxicity has been reported in

a patient with unrecognized cisplatin-induced oliguric renal failure.

Clinical Studies

Malignant Pleural Effusion

The safety and efficacy of bleomycin 60 units and tetracycline (1 g) as treatment for malignant pleural

effusion were evaluated in a multicenter, randomized trial. Patients were required to have cytologically

positive pleural effusion, good performance status (0,1,2), lung re-expansion following tube

thoracostomy with drainage rates of 100 mL/24 hours or less, no prior intrapleural therapy, no prior

systemic bleomycin therapy, no chest irradiation and no recent change in systemic therapy. Overall

survival did not differ between the bleomycin (n = 44) and tetracycline treatment (n = 41) groups. Of

patients evaluated within 30 days of instillation, the recurrence rate was 36% (10/28) with bleomycin

and 67% (18/27) with tetracycline (p = 0.023). Toxicity was similar between groups.

INDICATIONS AND USAGE

Bleomycin for injection should be considered a palliative treatment. It has been shown to be useful in

the management of the following neoplasms either as a single agent or in proven combinations with

other approved chemotherapeutic agents:

Squamous Cell Carcinoma

Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal

mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to bleomycin is

poorer in patients with previously irradiated head and neck cancer.

Lymphomas

Hodgkin's Disease, non-Hodgkin's lymphoma.

Testicular Carcinoma

Embryonal cell, choriocarcinoma, and teratocarcinoma.

Bleomycin for injection has also been shown to be useful in the management of:

Malignant Pleural Effusion

Bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion

and prevention of recurrent pleural effusions.

CONTRAINDICATIONS

Bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic

reaction to it.

WARNINGS

Patients receiving bleomycin must be observed carefully and frequently during and after therapy. It

should be used with extreme caution in patients with significant impairment of renal function or

compromised pulmonary function.

Pulmonary toxicities occur in 10% of treated patients. In approximately 1%, the nonspecific pneumonitis

induced by bleomycin progresses to pulmonary fibrosis and death. Although this is age and dose

related, the toxicity is unpredictable. Frequent roentgenograms are recommended (see ADVERSE

REACTIONS, Pulmonary).

A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion,

fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with

bleomycin. Since these reactions usually occur after the first or second dose, careful monitoring is

essential after these doses (see ADVERSE REACTIONS, Idiosyncratic Reactions).

Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been

reported. These toxicities may occur at any time after initiation of therapy.

Usage in Pregnancy

Pregnancy Category D

Bleomycin can cause fetal harm when administered to a pregnant woman. It has been shown to be

teratogenic in rats. Administration of intraperitoneal doses of 1.5 mg/kg/day to rats (about 1.6 times the

recommended human dose on a unit/m basis) on days 6 to 15 of gestation caused skeletal malformations,

shortened innominate artery and hydroureter. Bleomycin is abortifacient but not teratogenic in rabbits at

intravenous doses of 1.2 mg/kg/day (about 2.4 times the recommended human dose on a unit/m basis)

given on gestation days 6 to 18.

There have been no studies in pregnant women. If bleomycin is used during pregnancy, or if the patient

becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the

fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy

with bleomycin.

PRECAUTIONS

General

Patients with creatinine clearance values of less than 50 mL/min should be treated with caution and their

renal function should be carefully monitored during the administration of bleomycin. Lower doses of

bleomycin may be required in these patients than those with normal renal function (see CLINICAL

PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of bleomycin in humans is unknown. A study in F344-type male rats

demonstrated an increased incidence of nodular hyperplasia after induced lung carcinogenesis by

nitrosamines, followed by treatment with bleomycin. In another study where the drug was administered

to rats by subcutaneous injection at 0.35 mg/kg weekly (3.82 units/m weekly or about 30% at the

recommended human dose), necropsy findings included dose-related injection site fibrosarcomas as

well as various renal tumors. Bleomycin has been shown to be mutagenic both in vitro and in vivo. The

effects of bleomycin on fertility have not been studied.

Pregnancy

Pregnancy Category D

(see WARNINGS section).

Nursing Mothers

It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human

milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that

nursing be discontinued by women receiving bleomycin therapy.

Pediatric Use

Safety and effectiveness of bleomycin in pediatric patients have not been established.

Geriatric Use

In clinical trials, pulmonary toxicity was more common in patients older than 70 years than in younger

patients (see BOXED WARNING, WARNINGS, and ADVERSE REACTIONS, Pulmonary). Other

reported clinical experience has not identified other differences in responses between elderly and

younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Bleomycin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this

drug may be greater in patients with impaired renal function. Because elderly patients are more likely to

have decreased renal function, care should be taken in dose selection, and it may be useful to monitor

renal function.

ADVERSE REACTIONS

Pulmonary

The most serious side effects are pulmonary adverse reactions, occurring in approximately 10% of

treated patients. The most frequent presentation is pneumonitis occasionally progressing to pulmonary

fibrosis. Approximately 1% of patients treated have died of pulmonary fibrosis. Pulmonary toxicity is

both dose and age related, being more common in patients over 70 years of age and in those receiving

over 400 units total dose. This toxicity, however, is unpredictable and has been seen in young patients

receiving low doses.

Some published reports have suggested that the risk of pulmonary toxicity may be increased when

bleomycin is used in combination with G-CSF (filgrastim) or other cytokines. However, randomized

clinical studies completed to date have not demonstrated an increased risk of pulmonary complications

in patients treated with bleomycin and G-CSF.

Because of lack of specificity of the clinical syndrome, the identification of patients with pulmonary

toxicity due to bleomycin has been extremely difficult. The earliest symptom associated with bleomycin

pulmonary toxicity is dyspnea. The earliest sign is fine rales.

Radiographically, bleomycin-induced pneumonitis produces nonspecific patchy opacities, usually of

the lower lung fields. The most common changes in pulmonary function tests are a decrease in total lung

volume and a decrease in vital capacity. However, these changes are not predictive of the development

of pulmonary fibrosis.

The microscopic tissue changes due to bleomycin toxicity include bronchiolar squamous metaplasia,

reactive macrophages, atypical alveolar epithelial cells, fibrinous edema, and interstitial fibrosis. The

acute stage may involve capillary changes and subsequent fibrinous exudation into alveoli producing a

change similar to hyaline membrane formation and progressing to a diffuse interstitial fibrosis

resembling the Hamman-Rich syndrome. These microscopic findings are nonspecific; e.g., similar

changes are seen in radiation pneumonitis and pneumocystic pneumonitis.

To monitor the onset of pulmonary toxicity, roentgenograms of the chest should be taken every 1 to 2

weeks (see WARNINGS). If pulmonary changes are noted, treatment should be discontinued until it can

be determined if they are drug related. Recent studies have suggested that sequential measurement of

the pulmonary diffusion capacity for carbon monoxide (DL

) during treatment with bleomycin may be

an indicator of subclinical pulmonary toxicity. It is recommended that the DL

be monitored monthly if

it is to be employed to detect pulmonary toxicities, and thus the drug should be discontinued when the

falls below 30% to 35% of the pretreatment value.

Because of bleomycin's sensitization of lung tissue, patients who have received bleomycin are at

greater risk of developing pulmonary toxicity when oxygen is administered in surgery. While long

exposure to very high oxygen concentrations is a known cause of lung damage, after bleomycin

administration, lung damage can occur at lower concentrations that are usually considered safe.

Suggested preventive measures are:

1. Maintain FlO at concentrations approximating that of room air (25%) during surgery and the

postoperative period.

2. Monitor carefully fluid replacement, focusing more on colloid administration rather than crystalloid.

Sudden onset of an acute chest pain syndrome suggestive of pleuropericarditis has been reported during

bleomycin infusions. Although each patient must be individually evaluated, further courses of

bleomycin do not appear to be contraindicated.

Pulmonary adverse events which may be related to the intrapleural administration of bleomycin have

been reported.

Idiosyncratic Reactions

In approximately 1% of the lymphoma patients treated with bleomycin, an idiosyncratic reaction, similar

to anaphylaxis clinically, has been reported. The reaction may be immediate or delayed for several

hours, and usually occurs after the first or second dose (see WARNINGS). It consists of hypotension,

mental confusion, fever, chills, and wheezing. Treatment is symptomatic including volume expansion,

pressor agents, antihistamines, and corticosteroids.

Integument and Mucous Membranes

These adverse reactions have been reported in approximately 50% of treated patients. They consist of

erythema, rash, striae, vesiculation, hyperpigmentation, and tenderness of the skin. Hyperkeratosis, nail

changes, alopecia, pruritus, and stomatitis have also been reported. It was necessary to discontinue

bleomycin therapy in 2% of treated patients because of these toxicities.

Scleroderma-like skin changes have been reported.

Skin toxicity is a relatively late manifestation usually developing in the second and third week of

treatment after 150 to 200 units of bleomycin have been administered and appears to be related to the

cumulative dose.

Intrapleural administration of bleomycin has been associated with local pain. Hypotension possibly

requiring symptomatic treatment has been reported. Death has been reported in association with

bleomycin pleurodesis in seriously ill patients.

Other

Vascular toxicities coincident with the use of bleomycin in combination with other antineoplastic agents

have been reported. The events are clinically heterogeneous and may include myocardial infarction,

cerebrovascular accident, thrombotic microangiopathy (HUS) or cerebral arteritis. Various mechanisms

have been proposed for these vascular complications. There are also reports of Raynaud's phenomenon

occurring in patients treated with bleomycin in combination with vinblastine with or without cisplatin or,

in a few cases, with bleomycin as a single agent. It is currently unknown if the cause of Raynaud's

phenomenon in these cases is the disease, underlying vascular compromise, bleomycin, vinblastine,

hypomagnesemia, or a combination of any of these factors.

Fever, chills, and vomiting have been reported. Anorexia and weight loss have been reported and may

persist long after termination of this medication. Pain at tumor site, phlebitis, and other local reactions

have been reported.

Malaise has been reported.

DOSAGE AND ADMINISTRATION

BECAUSE OF THE POSSIBILITY OF AN ANAPHYLACTOID REACTION, LYMPHOMA

PATIENTS SHOULD BE TREATED WITH 2 UNITS OR LESS FOR THE FIRST TWO

DOSES. IF NO ACUTE REACTION OCCURS, THEN THE REGULAR DOSAGE SCHEDULE

MAY BE FOLLOWED.

The following dose schedule is recommended:

Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma - 0.25 to 0.50 units/kg (10 to

20 units/m ) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.

Hodgkin's Disease - 0.25 to 0.50 units/kg (10 to 20 units/m ) given intravenously, intramuscularly, or

subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5

units weekly intravenously or intramuscularly should be given.

Pulmonary toxicity of bleomycin appears to be dose related with a striking increase when the total dose

is over 400 units. Total doses over 400 units should be given with great caution.

Note: When bleomycin is used in combination with other antineoplastic agents, pulmonary

toxicities may occur at lower doses.

Improvement of Hodgkin's Disease and testicular tumors is prompt and noted within 2 weeks. If no

improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly,

sometimes requiring as long as 3 weeks before any improvement is noted.

Malignant Pleural Effusion - 60 units administered as a single dose bolus intrapleural injection (see

Administration, Intrapleural).

Use in Patients with Renal Insufficiency

The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of

less than 50 mL/min:

Patient CrCL

(mL/min)

Bleomycin for Injection

Dose (%)

50 and above

40 to 50

30 to 40

20 to 30

10 to 20

5 to 10

CrCL can be estimated from the individual patient’s measured serum creatinine (Scr) values using the

Cockcroft and Gault formula:

Males CrCL = [weight x (140 – Age)]/(72 x Scr)

Females CrCL = 0.85 x [weight x (140 – Age)]/(72 x Scr)

Where CrCL in mL/min/1.73m , weight in kg, age in years, and Scr in mg/dL.

Adminis tration

Bleomycin for injection may be given by the intramuscular, intravenous, subcutaneous, or intrapleural

routes.

Administration Precautions

Caution should be exercised when handling bleomycin for injection. Procedures for proper handling

and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been

published.

To minimize the risk of dermal exposure, always wear impervious gloves when handling

vials containing bleomycin for injection. If bleomycin for injection contacts the skin, immediately wash

the skin thoroughly with soap and water. If contact with mucous membranes occurs, the membranes

should be flushed immediately and thoroughly with water. More information is available in the

references listed below.

Intramuscular or Subcutaneous

The bleomycin for injection 15 units vial should be reconstituted and dissolved with 1 to 5 mL of sterile

water for injection, USP, sodium chloride injection, 0.9%, USP, or bacteriostatic water for injection,

USP. The bleomycin for injection 30 units vial should be reconstituted and dissolved with 2 to 10 mL of

the above diluents.

Intravenous

The contents of the 15 units or 30 units vial should be dissolved in 5 mL or 10 mL, respectively, of

Sodium Chloride for Injection, 0.9%, USP, and administered slowly over a period of 10 minutes.

Intrapleural

60 units of bleomycin are dissolved in 50 to 100 mL Sodium Chloride for Injection, 0.9%, USP and

administered through a thoracostomy tube following drainage of excess pleural fluid and confirmation

of complete lung expansion. The literature suggests that successful pleurodesis is, in part, dependent

upon complete drainage of the pleural fluid and reestablishment of negative intrapleural pressure prior

to instillation of a sclerosing agent. Therefore, the amount of drainage from the chest tube should be as

minimal as possible prior to instillation of bleomycin. Although there is no conclusive evidence to

support this contention, it is generally accepted that chest tube drainage should be less than 100 mL in a

24-hour period prior to sclerosis. However, bleomycin instillation may be appropriate when drainage is

between 100 to 300 mL under clinical conditions that necessitate sclerosis therapy. The thoracostomy

tube is clamped after bleomycin instillation. The patient is moved from the supine to the left and right

lateral positions several times during the next four hours. The clamp is then removed and suction

reestablished. The amount of time the chest tube remains in place following sclerosis is dictated by the

clinical situation.

The intrapleural injection of topical anesthetics or systemic narcotic analgesia is generally not required.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

HOW SUPPLIED

Bleomycin for Injection USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of

bleomycin. Bleomycin for Injection USP is supplied as follows:

NDC Number

0703-3154-01

15 Units per Vial

Individually packaged

0703-3155-01

30 Units per Vial

Individually packaged

Stability

The sterile powder is stable under refrigeration 2° to 8°C (36° to 46°F) and should not be used after

the expiration date is reached.

Bleomycin for Injection USP should not be reconstituted or diluted with 5% dextrose injection or other

dextrose containing diluents. When reconstituted in 5% dextrose injection and analyzed by HPLC,

Bleomycin for Injection USP demonstrates a loss of A and B potency that does not occur when

Bleomycin for Injection USP is reconstituted in 0.9% sodium chloride for injection, 0.9%, USP.

Bleomycin for Injection USP is stable for 24 hours at room temperature in 0.9 % sodium chloride

injection.

Vial stoppers do not contain natural rubber latex.

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in

healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service,

Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health,

DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure

to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/ot m_vi_2.html

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am

J Health-Syst Pharm. 2006;63:1172-1193.

4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and

recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. B 2/2016

Package/Label Display Panel

Bleomycin for Injection USP 15 Units/Single Dose Vial Carton Text

NDC 0703-3154-01 Rx only

BLEOMYCIN

for Injection USP

equivalent to

15 Units/Vial

Bleomycin

CAUTION: Cytotoxic –

Special Handling Procedures

Single Dose Vial

For IV, IM, SC or

Intrapleural Use

TEVA

Package/Label Display Panel

Bleomycin for Injection USP 30 Units/Single Dose Vial Carton Text

NDC 0703-3155-01 Rx only

BLEOMYCIN

for Injection USP

equivalent to

30 Units/Vial

Bleomycin

CAUTION: Cytotoxic –

Special Handling Procedures

Single Dose Vial

For IV, IM, SC or

Intrapleural Use

TEVA

BLEOMYCIN

bleomycin injection, powder, lyophilized, for solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code

(S ource )

NDC:0 70 3-

3154

Route of Administration

INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS,

SUBCUTANEOUS

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BLEO MYCIN SULFATE (UNII: 7DP3NTV15T) (BLEOMYCIN - UNII:40 S1VHN6 9 B)

BLEOMYCIN

15 [USP'U]

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 70 3-3154-

1 in 1 CARTON

0 6 /30 /20 0 0

1

1 in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 50 33

0 6 /30 /20 0 0

BLEOMYCIN

bleomycin injection, powder, lyophilized, for solution

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code

(S ource )

NDC:0 70 3-

3155

Route of Administration

INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS,

SUBCUTANEOUS

Teva Parenteral Medicines, Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BLEO MYCIN SULFATE (UNII: 7DP3NTV15T) (BLEOMYCIN - UNII:40 S1VHN6 9 B)

BLEOMYCIN

30 [USP'U]

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:0 70 3-3155-

1 in 1 CARTON

0 6 /30 /20 0 0

1

1 in 1 VIAL, SINGLE-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 50 33

0 6 /30 /20 0 0

Labeler -

T eva Parenteral Medicines, Inc. (794362533)

Revised: 2/2016

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