Interferon Beta-1b (Extavia)

Trade Name : EXTAVIA

Novartis Pharmaceuticals Corporation

KIT

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Interferon Beta-1b (Extavia) which is also known as EXTAVIA and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of per ml. Read more

Interferon Beta-1b (Extavia) 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.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • EXTAVIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • EXTAVIA is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ()
  • No data
  • nttttttttttFor subcutaneous use only. ()
  • nttttttttttThe recommended dose is 0.25 mg every other day. Generally, start at 0.0625 mg (0.25 mL) every other day, and increase over a six-week period to 0.25 mg (1 mL) every other day. ()
  • nttttttttttReconstitute lyophilized powder with supplied diluent; the removable diluent cap contains natural rubber latex. ()
  • For injection: 0.3 mg white to off-white lyophilized powder in a single-dose vial for reconstitution.
  • For injection:
  • 3
  • 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.
  • History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol. ()
  • No data
  • Hepatic Injury:
  • Anaphylaxis and Other Allergic Reactions:
  • Depression and Suicide:
  • Congestive Heart Failure (CHF):
  • Injection Site Necrosis and Reactions:
  • Leukopenia:
  • Thrombotic Microangiopathy (TMA):
  • Flu-like Symptom Complex:
  • Drug-induced Lupus Erythematosus:
  • The following serious adverse reactions are discussed in more details in other sections of labeling:
  • In controlled clinical trials, the most common adverse reactions (at least 5% more frequent on interferon beta-1b than on placebo) were: injection-site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia. ()
  • Pregnancy:
  • 8.1
  • 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.
  • EXTAVIA (interferon beta-1b) for injection is a sterile, preservative-free, white to off-white lyophilized powder, for subcutaneous injection after reconstitution with the diluent supplied (0.54% Sodium Chloride Solution, USP). Each vial contains Albumin (Human) USP (15 mg) and Mannitol, USP (15 mg).
  • No data
  • Carcinogenesis
  • Interferon beta-1b has not been tested for its carcinogenic potential in animals.
  • Mutagenesis
  • Interferon beta-1b was not genotoxic in the bacterial reverse mutation assay or the chromosomal aberration assay in human peripheral blood lymphocytes. Interferon beta-1b treatment of mouse BALBc-3T3 cells did not result in increased transformation frequency in an model of tumor transformation.
  • Impairment of Fertility
  • Administration of interferon beta-1b (doses of up to 0.33 mg/kg/day) to normally cycling female rhesus monkeys had no apparent adverse effects on either menstrual cycle duration or associated hormonal profiles (progesterone and estradiol) when administered over three consecutive menstrual cycles. The highest dose tested is approximately 30 times the recommended human dose of 0.25 mg on a body surface area (mg/m) basis. The potential for other effects on fertility or reproductive performance was not evaluated.
  • The clinical effects of interferon beta-1b were studied in four randomized, multicenter, double-blind, placebo-controlled studies in patients with MS (Studies 1, 2, 3, and 4).
  • Patients with Relapsing-Remitting MS
  • The effectiveness of interferon beta-1b in relapsing-remitting MS (RRMS) was evaluated in a double blind, multiclinic, randomized, parallel, placebo controlled clinical study of two years duration (Study 1). The study enrolled MS patients, aged 18 to 50, who were ambulatory [Kurtzke Expanded Disability Status Scale (EDSS) of u2264 5.5-score 5.5 is ambulatory for 100 meters, disability precludes full daily activities], exhibited a relapsing-remitting clinical course, met Poseru2019s criteria for clinically definite and/or laboratory-supported definite MS and had experienced at least two exacerbations over two years preceding the trial without exacerbation in the preceding month. The EDSS score is a method of quantifying disability in patients with MS and ranges from 0 (normal neurologic exam) to 10 (death due to MS). Patients who had received prior immunosuppressant therapy were excluded.
  • An exacerbation was defined as the appearance of a new clinical sign/symptom or the clinical worsening of a previous sign/symptom (one that had been stable for at least 30 days) that persisted for a minimum of 24 hours.
  • Patients selected for study were randomized to treatment with either placebo (N = 123), 0.05 mg of interferon beta-1b (N = 125), or 0.25 mg of interferon beta-1b (N = 124), self-administered subcutaneously every other day. Outcome based on the 372 randomized patients was evaluated after two years.
  • Patients who required more than three 28-day courses of corticosteroids were removed from the study. Minor analgesics (acetaminophen, codeine), antidepressants, and oral baclofen were allowed ad libitum, but chronic nonsteroidal anti-inflammatory drug (NSAID) use was not allowed.
  • The primary protocol-defined outcome measures were 1) frequency of exacerbations per patient and 2) proportion of exacerbation-free patients. A number of secondary clinical and magnetic resonance imaging (MRI) measures were also employed. All patients underwent annual T2 MRI imaging, and a subset of 52 patients at one site had MRIs performed every six weeks for assessment of new or expanding lesions.
  • The study results are shown in Table 3.
  • Of the 372 RRMS patients randomized, 72 (19%) failed to complete two full years on their assigned treatments.
  • Over the two-year period in Study 1, there were 25 MS-related hospitalizations in the 0.25 mg interferon beta-1b-treated group compared to 48 hospitalizations in the placebo group. In comparison, non-MS hospitalizations were evenly distributed among the groups, with 16 in the 0.25 mg interferon beta-1b group and 15 in the placebo group. The average number of days of MS-related steroid use was 41 days in the 0.25 mg interferon beta-1b group and 55 days in the placebo group (p = 0.004).
  • MRI data were also analyzed for patients in this study. A frequency distribution of the observed percent changes in MRI area at the end of two years was obtained by grouping the percentages in successive intervals of equal width. Figure 1 displays a histogram of the proportions of patients, which fell into each of these intervals. The median percent change in MRI area for the 0.25 mg group was -1.1%, which was significantly smaller than the 16.5% observed for the placebo group (p = 0.0001).
  • Figure 1: Distribution of Change in MRI Area in Patients with RRMS in Study 1
  • In an evaluation of frequent MRI scans (every six weeks) on 52 patients at one site in Study 1, the percent of scans with new or expanding lesions was 29% in the placebo group and 6% in the 0.25 mg treatment group (p = 0.006).
  • Patients with Secondary Progressive MS
  • Studies 2 and 3 were multicenter, randomized, double-blind, placebo-controlled trials conducted to assess the effect of interferon beta-1b in patients with secondary progressive MS (SPMS). Study 2 was conducted in Europe, and Study 3 was conducted in North America. Both studies enrolled patients with clinically definite or laboratory-supported MS in the secondary progressive phase, and who had evidence of disability progression (both Study 2 and 3) or two relapses (Study 2 only) within the previous two years. Baseline Kurtzke EDSS scores ranged from 3.0 to 6.5. Patients in Study 2 were randomized to receive interferon beta-1b 0.25 mg (N = 360) or placebo (N = 358). Patients in Study 3 were randomized to interferon beta-1b 0.25 mg (N = 317), interferon beta-1b 0.16 mg/m of body surface area (N = 314, mean assigned dose 0.3 mg), or placebo (N = 308). Test agents were administered subcutaneously, every other day for three years.
  • The primary outcome measure was progression of disability, defined as a 1.0 point increase in the EDSS score, or a 0.5 point increase for patients with baseline EDSS u2265 6.0. In Study 2, time to progression in EDSS was longer in the interferon beta-1b treatment group (p = 0.005), with estimated annualized rates of progression of 16% and 19% in the interferon beta-1b and placebo groups, respectively. In Study 3, the rates of progression did not differ significantly between treatment groups, with estimated annualized rates of progression of 12%, 14%, and 12% in the interferon beta-1b fixed dose, surface area-adjusted dose, and placebo groups, respectively.
  • Multiple analyses, including covariate and subset analyses based on sex, age, disease duration, clinical disease activity prior to study enrollment, MRI measures at baseline, and early changes in MRI following treatment were evaluated in order to interpret the discordant study results. No demographic or disease-related factors enabled identification of a patient subset where interferon beta-1b treatment was predictably associated with delayed progression of disability.
  • In Studies 2 and 3, like Study 1, a statistically significant decrease in the incidence of relapses associated with interferon beta-1b treatment was demonstrated. In Study 2, the mean annual relapse rates were 0.42 and 0.63 in the interferon beta-1b and placebo groups, respectively (p < 0.001). In Study 3, the mean annual relapse rates were 0.16, 0.20, and 0.28, for the fixed dose, surface area-adjusted dose, and placebo groups, respectively (p < 0.02).
  • MRI endpoints in both Study 2 and Study 3 showed smaller increases in T2 MRI lesion area and decreased number of active MRI lesions in patients in the interferon beta-1b groups compared to the placebo group.
  • Patients with an Isolated Demyelinating Event and Typical MS Lesions on Brain MRI
  • In Study 4, 468 patients who had recently (within 60 days) experienced an isolated demyelinating event, and who had lesions typical of MS on brain MRI were randomized to receive either 0.25 mg interferon beta-1b (N = 292) or placebo (N = 176) subcutaneously every other day (ratio 5:3). The primary outcome measure was time to development of a second exacerbation with involvement of at least two distinct anatomical regions. Secondary outcomes were brain MRI measures, including the cumulative number of newly active lesions, and the absolute change in T2 lesion volume. Patients were followed for up to two years or until they fulfilled the primary endpoint. Eight percent of subjects on interferon beta-1b and 6% of subjects on placebo withdrew from the study for a reason other than the development of a second exacerbation. Time to development of a second exacerbation was significantly delayed in patients treated with interferon beta-1b compared to patients treated with placebo (p < 0.0001). The Kaplan-Meier estimates of the percentage of patients developing an exacerbation within 24 months were 45% in the placebo group and 28% of the interferon beta-1b group (Figure 2). The risk for developing a second exacerbation in the interferon beta-1b group was 53% of the risk in the placebo group (Hazard ratio = 0.53; 95% confidence interval 0.39 to 0.73).
  • Figure 2: Onset of Second Exacerbation by Time in Patients with Isolated Demyelinating Event with Typical MS Lesions on Brain MRI in Study 4*
  • *Kaplan-Meier Methodology
  • In Study 4, patients treated with interferon beta-1b demonstrated a lower number of newly active lesions during the course of the study. A significant difference between interferon beta-1b and placebo was not seen in the absolute change in T2 lesion volume during the course of the study.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • Instruction on Self-injection Technique and Procedures
  • Provide appropriate instruction for reconstitution of EXTAVIA and methods of self-injection, including careful review of the EXTAVIA Medication Guide. Instruct patients in the use of aseptic technique when administering EXTAVIA.
  • Tell patients not to re-use needles or syringes, and instruct patients on safe disposal procedures. Advise patients of the importance of rotating areas of injection with each dose, to minimize the likelihood of severe injection-site reactions, including necrosis or localized infection .
  • Hepatic Injury
  • Advise patients that severe hepatic injury, including hepatic failure, has been reported during the use of EXTAVIA.
  • Inform patients of symptoms of hepatic dysfunction, and instruct patients to report them immediately to their healthcare provider .
  • Anaphylaxis and Other Allergic Reactions
  • Advise patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients to seek immediate medical attention if these symptoms occur. Inform latex-sensitive patients that the removable rubber cap of the diluent pre-filled syringe contains natural rubber latex .
  • Depression and Suicide
  • Advise patients that depression and suicidal ideation have been reported during the use of EXTAVIA. Inform patients of the symptoms of depression or suicidal ideation, and instruct patients to report them immediately to their healthcare provider .
  • Congestive Heart Failure
  • Advise patients that worsening of preexisting congestive heart failure have been reported in patients using EXTAVIA.
  • Advise patients of symptoms of worsening cardiac condition, and instruct patients to report them immediately to their healthcare provider .
  • Injection-Site Necrosis and Reactions
  • Advise patients that injection-site reactions occur in most patients treated with EXTAVIA, and that injection-site necrosis may occur at one or multiple sites. Instruct patients to promptly report any break in the skin, which may be associated with blue-black discoloration, swelling, or drainage of fluid from the injection site, prior to continuing their EXTAVIA therapy .
  • Flu-like Symptom Complex
  • Inform patients that flu-like symptoms are common following initiation of therapy with EXTAVIA, and that concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with EXTAVIA use n
  • Seizures
  • Instruct patients to report seizures immediately to their healthcare provider .
  • Drug-induced Lupus Erythematosus
  • Advise patients that drug-induced lupus erythematosus has been reported during the use of EXTAVIA. Inform patients of the symptoms of rash, redness of the skin on the face, joint pain, fever and weakness, and instruct patients to report them immediately to their healthcare provider n
  • Pregnancy
  • Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant .
  • Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936U.S. License No. 1244
  • u00a9 Novartis
  • T2019-94
  • Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936U.S. License No. 1244
  • T2019-95
  • EXTAVIA (interferon beta-1b) Patient Instructions for Use
  • If your doctor decides that you or a caregiver may be able to give your injections of EXTAVIA at home, your doctor or nurse should instruct you on the right way to prepare and inject EXTAVIA. To lower your risk of infection, it is important that you follow the technique that your doctor or nurse discussed with you to prepare and inject EXTAVIA.Do not try to inject EXTAVIA yourself until you have been shown by your doctor or nurse the right way to prepare and give the injections.
  • It is important for you to read, understand, and follow these instructions. Call your doctor if you or your caregiver has any questions about the right way to prepare or inject EXTAVIA.
  • Important safety information
  • Figure 1
  • Gather your supplies.
  • You will need the following supplies to get ready to give your injection of EXTAVIA:
  • Figure 2
  • Figure 3
  • Prepare for self-injection
  • Figure 4
  • Mix EXTAVIA
  • 4.nttu00a0u00a0u00a0u00a0u00a0ntRemove the EXTAVIA vial from the well and take the cap off the vial (Figure 5).
  • Figure 5
  • 5.nttu00a0u00a0u00a0u00a0u00a0ntPlace the vial back in the vial holder.
  • 6.nttu00a0u00a0u00a0u00a0u00a0ntUse an alcohol wipe to clean the top of the vial (Figure 6). Wipe in one direction only.
  • Figure 6
  • 7.nttu00a0u00a0u00a0u00a0u00a0ntLeave the alcohol wipe on top of the vial until step 9 below.
  • 8.nttu00a0u00a0u00a0u00a0u00a0ntPeel the label off the container with the vial adapter in it, but do not remove the vial adapter. The vial adapter is sterile, so do not touch it.
  • 9.nttu00a0u00a0u00a0u00a0u00a0ntRemove the alcohol wipe from the top of the vial. Pick up the container that holds the vial adapter. Turn over the container keeping the vial adaptor inside. Put the adapter on top of the vial. Push down on the adapter until it pierces the rubber top of the vial and snaps in place (Figure 7). Lift the container off the vial adapter.
  • Figure 7
  • 10.nttu00a0u00a0u00a0u00a0u00a0ntRemove the rubber cap from the pre-filled syringe using a twist and pull motion (Figure 8). Throw away the rubber cap.
  • Figure 8
  • 11.nttu00a0u00a0u00a0u00a0u00a0ntRemove the vial from the vial holder by grasping the vial. Do not touch any part of the vial adapter. Be careful not to pull the vial adapter off the top of the vial.
  • 12.nttu00a0u00a0u00a0u00a0u00a0ntConnect the pre-filled syringe of diluent to the vial adapter by turning clockwise and tighten carefully (Figure 9).
  • Figure 9
  • 13.nttu00a0u00a0u00a0u00a0u00a0ntSlowly push the plunger of the pre-filled syringe all the way in. This will push all of the liquid from the syringe into the vial (Figure 10). Continue to hold the plunger while you mix EXTAVIA with the liquid from the syringe. If you do not hold the plunger in, it may return to its original position after you let go.
  • Figure 10
  • 14.nttu00a0u00a0u00a0u00a0u00a0ntGently swirl the vial to completely dissolve the white powder (EXTAVIA). Shaking and even gentle mixing can cause foaming of the medicine. If there is foam, let the vial sit until the foam settles.
  • 15.nttu00a0u00a0u00a0u00a0u00a0ntAfter the powder dissolves, look closely at the solution in the vial. Do not use the solution if it is not clear or colorless, or if it contains particles.
  • The injection should be given right away after you mix EXTAVIA and let any foam in the solution settle. If you must wait for any reason before giving yourself the injection, you may refrigerate the medicine after you mix it. But you should use it within three hours.
  • 16.nttu00a0u00a0u00a0u00a0u00a0ntWith your thumb still pushing the plunger, turn the syringe and vial, so that the vial is on top (Figure 11).
  • 17.nttu00a0u00a0u00a0u00a0u00a0ntSlowly pull the plunger back to withdraw the entire contents of the vial into the syringe.
  • Figure 11
  • 18.nttu00a0u00a0u00a0u00a0u00a0ntTurn the syringe so that the needle end is pointing up. Remove any air bubbles by tapping the outside of the syringe with your fingers (Figure 12). Slowly push the plunger to the 1 mL mark on the syringe or to the mark that matches the amount of EXTAVIA prescribed by your doctor. If too much solution is pushed back into the vial, return to step 16.
  • Figure 12
  • 19.nttu00a0u00a0u00a0u00a0u00a0ntRemove the vial adapter and the vial from the syringe by twisting the vial adapter (Figure 13).
  • Figure 13
  • Choose an Injection Site
  • Figure 14
  • Injecting EXTAVIA
  • 20.nttu00a0u00a0u00a0u00a0u00a0ntUsing a circular motion, clean the injection site with an alcohol wipe, starting at the injection site and moving outward (Figure 15). Let the skin area air dry.
  • Figure 15
  • 21.nttu00a0u00a0u00a0u00a0u00a0ntRemove the cap from the needle (Figure 16).
  • Figure 16
  • 22.nttu00a0u00a0u00a0u00a0u00a0ntGently pinch the skin around the site with your thumb and forefinger of the other hand (Figure 17). Insert the needle straight up and down into your skin at a 90u02da angle with a quick, dart-like motion.
  • Figure 17
  • 23.nttu00a0u00a0u00a0u00a0u00a0ntOnce the needle is in your skin, slowly pull back on the plunger. If blood appears in the syringe, it means that you have entered a blood vessel. Do not inject EXTAVIA. Withdraw the needle. Throw away the syringe and needle in your puncture-proof container. Do not use the same syringe or any of the other supplies that you used for this injection. Repeat the above steps to prepare your dose using a new blister pack. Choose and clean a new injection site.
  • 24.nttu00a0u00a0u00a0u00a0u00a0ntIf no blood appears in the syringe, slowly push the plunger all the way in until the syringe is empty (Figure 18). Remove the needle from the skin; then place a dry cotton ball or gauze pad over the injection site. Gently massage the injection site for a few minutes with the dry cotton ball or gauze pad. Throw away the syringe in your puncture-proof disposal container.
  • Figure 18
  • Dispose of used syringes, needles, and vialsn- u00a0
  • Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936U.S. License No. 1244
  • This Instruction for Use has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0August 2019
  • u00a9 Novartis
  • T2019-96
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0569-12nttu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntNOVARTIS
  • EXTAVIAn
  • (interferon beta-1b)
  • 0.3 mg per vial
  • For subcutaneous use onlyu00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0nttRx only
  • Dispense the enclosed Medication Guide to each patient.
  • Each blister pack contains:
  • Dispense in this unit-of-use container.u00a0u00a0u00a0u00a0u00a0nnttu00a0u00a0u00a0u00a0u00a0ntt15 single dose blister packs

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