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Interferon beta-1b

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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.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The mechanism of action of EXTAVIA (interferon beta-1b) in patients with multiple sclerosis is unknown.

Non-Clinical Toxicology
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.

Interactions Common for Both Benazepril and Hydrochlorothiazide

Potassium Supplements and Potassium-Sparing Diuretics:

mTOR (mammalian target of rapamycin) inhibitors:

Lithium:

Dual Blockade of the Renin-Angiotensin System (RAS):

Do not co-administer aliskiren with Benazepril HCl and Hydrochlorothiazide in patients with diabetes. Avoid use of aliskiren with Benazepril HCl and Hydrochlorothiazide in patients with renal impairment (GFR <60 ml/min).

NSAIDs and Cox-2 selective agents:

The antihypertensive effect of benazepril and hydrochlorothiazide may be attenuated by NSAIDs.

Benazepril

Benazepril has been used concomitantly with beta-adrenergic-blocking agents, calcium-blocking agents, cimetidine, diuretics, digoxin, hydralazine, and naproxen without evidence of clinically important adverse interactions. Other ACE inhibitors have had less than additive effects with beta-adrenergic blockers, presumably because drugs of both classes lower blood pressure by inhibiting parts of the renin-angiotensin system.

Interaction studies with warfarin and acenocoumarol have failed to identify any clinically important effects of benazepril on the serum concentrations or clinical effects of these anticoagulants.

Gold:

Hydrochlorothiazide

Ion exchange resins: Stagger the dosage of hydrochlorothiazide and ion exchange resins such that hydrochlorothiazide is administered at least 4 hours before or 4-6 hours after the administration of resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively.

Digitalis glycosides:

Skeletal muscle relaxants:

Antidiabetic agents:

Antineoplastic agents

Drugs that alter gastrointestinal motility:

Cyclosporin:

Alcohol, barbiturates, or narcotics:

Pressor amines:

Severe hepatic injury including cases of hepatic failure, some of which have been due to autoimmune hepatitis, has been rarely reported in patients taking EXTAVIA. In some cases, these events have occurred in the presence of other drugs or comorbid medical conditions that have been associated with hepatic injury. Consider the potential risk of EXTAVIA used in combination with known hepatotoxic drugs or other products (e.g., alcohol) prior to EXTAVIA administration, or when adding new agents to the regimen of patients already on EXTAVIA. Monitor patients for signs and symptoms of hepatic injury. Consider discontinuing EXTAVIA if serum transaminase levels significantly increase, or if they are associated with clinical symptoms such as jaundice.

Asymptomatic elevation of serum transaminases is common in patients treated with EXTAVIA. In controlled clinical trials, elevations of SGPT to greater than five times baseline value were reported in 12% of patients receiving interferon beta-1b (compared to 4% on placebo), and increases of SGOT to greater than five times baseline value were reported in 4% of patients receiving interferon beta-1b (compared to 1% on placebo), leading to dose-reduction or discontinuation of treatment in some patients . Monitor liver function tests

The following serious adverse reactions are discussed in more details in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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