BORTEZOMIB- bortexomib injection, powder, lyophilized, for solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Bortezomib (UNII: 69G8BD63PP) (Bortezomib - UNII:69G8BD63PP)

Dostupné s:

Dr.Reddy's Laboratories Inc

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Bortezomib for injection is indicated for the treatment of adult patients with multiple myeloma. Bortezomib for injection is indicated for the treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy. Bortezomib for injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib or boron. Reactions have included anaphylactic reactions [see Adverse Reactions (6.1)].  Bortezomib for injection is contraindicated for intrathecal administration. Fatal events have occurred with intrathecal administration of bortezomib products. Risk Summary Based on its mechanism of action [see Clinical Pharmacology (12.1)] and findings in animals, bortezomib can cause fetal harm when administered to a pregnant woman. There are no studies with the use of bortezomib in pregnant women to inform drug-associated risks. Bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose (see Data). Advise pregnant women of the potential risk to the fetus.  Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Bortezomib was not teratogenic in nonclinical developmental toxicity studies in rats and rabbits at the highest dose tested (0.075 mg/kg; 0.5 mg/m2  in the rat and 0.05 mg/kg; 0.6 mg/m2 in the rabbit) when administered during organogenesis. These dosages are approximately 0.5 times the clinical dose of 1.3 mg/m2  based on body surface area.  Bortezomib caused embryo-fetal lethality in rabbits at doses lower than the clinical dose (approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area). Pregnant rabbits given bortezomib during organogenesis at a dose of 0.05mg/kg (0.6 mg/m2 ) experienced significant postimplantation loss and decreased number of live fetuses. Live fetuses from these litters also showed significant decreases in fetal weight. Risk Summary There are no data on the presence of bortezomib or its metabolites in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Because many drugs are excreted in human milk and because the potential for serious adverse reactions in breastfed child from bortezomib is unknown, advise nursing women not to breastfeed during treatment with Bortezomib for injection and for two months after treatment. Based on its mechanism of action and findings in animals, with bortezomib can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Pregnancy Testing Conduct pregnancy testing in females of reproductive potential prior to initiating Bortezomib for injection treatment. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with Bortezomib for injection and for least seven months after the last dose. Males Males with female partners of reproductive potential should use effective contraception during treatment with Bortezomib for injection and for four months after the last dose. Infertility Based on the mechanism of action and findings in animals, Bortezomib for injection may have an effect on either male or female fertility [see Nonclinical Toxicology (13.1)].  Additional information describing a clinical study in which efficacy was not demonstrated in pediatric patients is in the approved label for Millennium Pharmaceuticals, Inc.'s VELCADE (bortezomib) Injection. However, due to Millennium Pharmaceuticals, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Of the 669 patients enrolled in the relapsed multiple myeloma study, 245 (37%) were 65 years of age or older: 125 (38%) on the bortezomib arm and 120 (36%) on the dexamethasone arm. Median time to progression and median duration of response for patients ≥65 were longer on bortezomib compared to dexamethasone [5.5 mo vs 4.3 mo, and 8 mo vs 4.9 mo, respectively]. On the bortezomib arm, 40% (n=46) of evaluable patients aged ≥65 experienced response (CR+PR) vs 18% (n=21) on the dexamethasone arm. The incidence of Grade 3 and 4 events was 64%, 78% and 75% for bortezomib patients ≤50, 51 to 64 and ≥65 years old, respectively [see Adverse Reactions ( 6.1), Clinical Studies (14.1)] . No overall differences in safety or effectiveness were observed between patients ≥ age 65 and younger patients receiving bortezomib; but greater sensitivity of some older individuals cannot be ruled out. No starting dosage adjustment of Bortezomib for injection is recommended for patients with renal impairment. In patients requiring dialysis, Bortezomib for injection should be administered after the dialysis procedure [see Clinical Pharmacology (12.3)]. No starting dosage adjustment of Bortezomib for injection is recommended for patients with mild hepatic impairment (total bilirubin ≤1x ULN and AST > ULN, or total bilirubin >1 to 1.5x ULN and any AST). The exposure of bortezomib is increased in patients with moderate (total bilirubin ≥1.5 to 3x ULN and any AST) and severe (total bilirubin >3x ULN and any AST) hepatic impairment. Reduce the starting dose in patients with moderate or severe hepatic impairment [see Dosage and Administration (2.6), Clinical Pharmacology ( 12.3) ]. During clinical trials, hypoglycemia and hyperglycemia were reported in diabetic patients receiving oral hypoglycemics. Patients on oral antidiabetic agents receiving Bortezomib for injection treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetic medication.

Přehled produktů:

Bortezomib for injection is supplied as individually cartoned 10 mL vials containing 3.5 mg of bortezomib as a white to off-white cake or powder. 3.5 mg single-dose vial NDC 43598-865-60 Store at 20°-25°C (68°-77°F). Retain in original package to protect from light.  Follow guidelines for handling and disposal for hazardous drugs, including the use of gloves and other protective clothing to prevent skin contact1 .

Stav Autorizace:

New Drug Application

Charakteristika produktu

BORTEZOMIB- BORTEXOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
DR.REDDY'S LABORATORIES INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BORTEZOMIB SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BORTEZOMIB.
BORTEZOMIB FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Bortezomib for injection is a proteasome inhibitor indicated for:
treatment of adult patients with multiple myeloma (1.1)
treatment of adult patients with mantle cell lymphoma who have
received at least 1 prior therapy (1.2)
DOSAGE AND ADMINISTRATION
For intravenous use only (2.1)
The recommended starting dose of bortezomib is 1.3 mg/m administered
as a 3 to 5 second bolus
intravenous injection (2.2, 2.4)
Retreatment for Multiple Myeloma: May retreat starting at the last
tolerated dose. (2.4)
Hepatic Impairment:Use a lower starting dose for patients with
moderate or severe hepatic
impairment. (2.6)
Dose must be individualized to prevent overdose (2.8)
DOSAGE FORMS AND STRENGTHS
For injection: Single-dose vial contains 3.5 mg of bortezomib as
lyophilized powder for reconstitution and
withdrawal of the appropriate individual patient dose. (3)
CONTRAINDICATIONS
Patients with hypersensitivity (not including local reactions) to
bortezomib or boron including
anaphylactic reactions. (4)
Contraindicated for intrathecal administration. (4)
WARNINGS AND PRECAUTIONS
Peripheral Neuropathy: Manage with dose modification or
discontinuation. (2.5) Patients with pre-
existing severe neuropathy should be treated with Bortezomib for
injection only after careful risk-
benefit assessment. (2.5, 5.1)
Hypotension: Use caution when treating patients taking
antihypertensives, with a history of syncope, or
with dehydration. (5.2)
Cardiac Toxicity: Worsening of and development of cardiac failure has
occurred. Closely monitor
patients with existing heart disease or risk factors for heart
disease. (5.3)
Pulmonary Toxicity: Acute respiratory syndromes have o