palifermin (Kepivance)

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Trade Name: Kepivance

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Swedish Orphan Biovitrum AB (publ)

Presentation: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 6.25 mg/1.2mL

Storage and handling

PALIFERMIN Fibroblast Growth Factor 7 [CS],Increased Epithelial Proliferation [PE],Mucocutaneous Epithelial Cell Growth Factor [EPC]

Disclaimer:

These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

No data

Limitations of Use

Administer as an intravenous bolus injection at a dose of 60u00a0mcg/kg/day for 3 consecutive days before and 3 consecutive days after myelotoxic therapy for a total of 6 doses (n n n )nn nn

Administer the first 3 doses prior to myelotoxic therapy with the third dose 24 to 48 hours before myelotoxic therapy (n n n )nn n n
Administer the last 3 doses after myelotoxic therapy is complete with the first of these doses on the day of hematopoietic stem cell infusion after the infusion is completed, and at least 7 days after the most recent administration of Kepivance (n n n )nn n n

For injection: 6.25 mg lyophilized powder in single-dose vials.n
For injection: 6.25 mg lyophilized powder in single-dose vials (n n n )nn nn

Nonen
Nonen

The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. The effects of Kepivance on stimulation of KGF receptor-expressing, non-hematopoietic tumors in patients are not known. Kepivance has been shown to enhance the growth of human epithelial tumor cell lines n n n and to increase the rate of tumor cell line growth in a human carcinoma xenograft model n n n n
Potential for stimulation of tumor growth u2014 Kepivance is not indicated for non-hematologic tumors. The effects of Kepivance on stimulation of keratinocyte growth factor (KGF) receptor-expressing, non-hematopoietic tumors in patients are not known (n n n , n n n )nn nn

Most common adverse reactions (incidence u226520% and 5%u2265placebo) are rash, fever, elevated serum amylase, pruritus, erythema, and edema (n n n )nn nn

In vitron- in vivon- [see Clinical Pharmacology (n n n )]n n n
Do not administer Kepivance within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy n n n In a clinical trial, administration of Kepivance within 24 hours of chemotherapy resulted in increased severity and duration of oral mucositis.nn nn

Heparin increases systemic exposure; flush intravenous line between heparin and Kepivance. (n n n )nn n n
Do not administer within 24 hours of myelotoxic chemotherapy. (n n n , n n n )nn n n

No data

Pregnancy: Based on animal data, may cause fetal harm (n n n )nn n n
Lactation: Breastfeeding not recommendedn n n )nn n n

Kepivance (palifermin) is a truncated human KGF produced by recombinant DNA technology in n n n . Kepivance is a water soluble, 140 amino acid protein with a molecular weight of 16.3 kilodaltons. It differs from endogenous human KGF in that the first 23 N terminal amino acids have been deleted to improve protein stability.nn nn
Kepivance is supplied as a sterile, white, preservative-free, lyophilized powder for intravenous injection after reconstitution with 1.2 mL of Sterile Water for Injection, USP. Reconstitution yields a clear, colorless solution of Kepivance (5 mg/mL) with a pH of 6.5. Each single-dose vial of Kepivance contains palifermin (6.25 mg),with L histidine (1.94 mg), mannitol (50 mg), polysorbate 20 (0.13 mg or 0.01% w/v), and sucrose (25 mg).n

No data

Palifermin was not carcinogenic in a 26-week study in rasH2 transgenic mice at intravenous doses of 0.1, 1, or 10 mg/kg/dose.n
Palifermin was not genotoxic in the reverse mutation bacterial (Ames) test, cytogenic test, or rat micronucleus assay.n
In a fertility and early embryonic development study, palifermin was administered intravenously to male and female rats at doses of 100, 300 or 1000 u03bcg/kg/day. Males were dosed 28 days prior to mating through cohabitation and females were dosed 14 days prior to mating through gestation Day 7. Decreased epididymal sperm counts, and increased post-implantation losses were observed at doses u2265 300 u03bcg/kg/day (5 fold the recommended human dose, on a body weight basis). Increased pre-implantation loss and decreased fertility index, were observed at a palifermin dose of 1000 u03bcg/kg/day.n

No data

Kepivance is supplied as a lyophilized powder in single-dose vials containing 6.25 mg of palifermin.n
Kepivance vials are supplied in:n
Store Kepivance vials in the dispensing pack in its carton refrigerated at 2u00b0 to 8u00b0C (36u00b0 to 46u00b0F) until time of use. Protect from light.n

Advise patients to report the following to healthcare providers:n
Inform patientsn
sobin n n SWEDISH ORPHAN BIOVITRUMn n n Manufactured byn n n
u00a9 Swedish Orphan Biovitrum AB (publ). All rights reserved.n

Principal Display Panel - 6.25 mg/1.2 mL Carton Label
6 x 6.25 mg/vial Single Use Vials
sobi
Kepivancen- Arrayn- Array
For Injectionn
6.25 mg/vial
Dosage - See Package Insertn
No U.S. Standard of Potencyn
US Patent Numbers:n
6,420,531 B1; 5,824,643; and 5,677,278n

Principal Display Panel - 6.25 mg/1.2 mL Carton Label
3 x 6.25 mg/vial Single Use Vials
sobi
Kepivancen- Arrayn- Array
For Injectionn
6.25 mg/vial
Dosage - See Package Insertn
No U.S. Standard of Potencyn
US Patent Numbers:n
6,420,531 B1; 5,824,643; and 5,677,278n

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of palifermin (Kepivance) which is also known as Kepivance and Manufactured by Swedish Orphan Biovitrum AB (publ). It is available in strength of 6.25 mg/1.2mL.

palifermin (Kepivance) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.