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Interferon beta-1b
Overview
What is EXTAVIA?
EXTAVIA (interferon beta-lb) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of that bears a genetically engineered plasmid containing the gene for human interferon beta. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material.
The specific activity of EXTAVIA is approximately 32 million international units (IU)/mg interferon beta-lb. Each vial contains 0.3 mg of interferon beta-lb. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and Albumin (Human), USP (15 mg each/vial) are added as stabilizers.
Lyophilized EXTAVIA is a sterile, white to off-white powder, for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution). Each vial contains Albumin (Human) USP (15 mg) and Mannitol, USP (15 mg).
What does EXTAVIA look like?
What are the available doses of EXTAVIA?
For injection:
3
What should I talk to my health care provider before I take EXTAVIA?
Pregnancy:
8.1
How should I use EXTAVIA?
EXTAVIA (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.
The recommended starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, with dose increases over a six-week period to the recommended dose of 0.25 mg (1 mL) every other day (see Table 1).
If a dose of EXTAVIA is missed, then it should be taken as soon as the patient remembers or is able to take it. The patient should not take EXTAVIA on two consecutive days. The next injection should be taken about 48 hours (two days) after that dose. If the patient accidentally takes more than their prescribed dose, or takes it on two consecutive days, they should be instructed to call their healthcare provider immediately.
What interacts with EXTAVIA?
Sorry No Records found
What are the warnings of EXTAVIA?
Sorry No Records found
What are the precautions of EXTAVIA?
Sorry No Records found
What are the side effects of EXTAVIA?
Sorry No records found
What should I look out for while using EXTAVIA?
EXTAVIA is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation.
What might happen if I take too much EXTAVIA?
Sorry No Records found
How should I store and handle EXTAVIA?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.How SuppliedNateglinide Tablets, USP are supplied in the following package and dose strength forms:60 mg Pink color coated, round biconvex, beveled edge tablet debossed with “P 984” on one side and plain on the other side. Bottles of 100……………NDC 60429-434-01120 mg Orange color coated, oval shaped biconvex, tablet debossed with “P 985” on one side and plain on the other side. Bottles of 100……………NDC 60429-435-01Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]Dispense in a tight, light resistant container.
