Saquinavir Mesylate (Invirase)

Trade Name : Invirase

Genentech, Inc.

TABLET, FILM COATED

Strength 500 mg/1

SAQUINAVIR MESYLATE HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Saquinavir Mesylate (Invirase) which is also known as Invirase and Manufactured by Genentech, Inc.. It is available in strength of 500 mg/1 per ml. Read more

Saquinavir Mesylate (Invirase) 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
  • INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV-1 infection in adults (over the age of 16 years).
  • The following points should be considered when initiating therapy with INVIRASE/ritonavir:
  • INVIRASE is an HIV-1 protease inhibitor indicated for the treatment of HIV-1 infection in combination with ritonavir and other antiretroviral agents in adults (over the age of 16 years). ()
  • INVIRASE must be used in combination with ritonavir because ritonavir significantly inhibits saquinavir's metabolism to provide increased plasma saquinavir levels.
  • Cobicistat is not interchangeable with ritonavir to increase systemic exposure of saquinavir .
  • INVIRASE must be administered in combination with ritonavir. ()
  • Adults (over the age of 16 years): INVIRASE 1,000 mg twice daily (2 u00d7 500 mg tablets) in combination with ritonavir 100 mg twice daily. ()
  • Treatment-nau00efve patients initiating treatment with INVIRASE/ritonavir: First 7 days of treatment: INVIRASE 500 mg twice daily with ritonavir 100 mg twice daily. After 7 days: INVIRASE 1,000 mg twice daily with ritonavir 100 mg twice daily. ()
  • See Full Prescribing Information for dosing recommendations for patients switching immediately from treatment with another protease inhibitor taken with ritonavir or from a non-nucleoside reverse transcriptase inhibitor based regimen, without a wash-out period. ()
  • INVIRASE and ritonavir should be taken within 2 hours after a meal. ()
  • Tablets: 500-mg light orange to greyish or brownish orange, oval cylindrical, biconvex film-coated with ROCHE and SQV 500 imprinted on the tablet faceCapsules (hard gel): 200-mg light brown and green opaque with ROCHE and 0245 imprinted on the capsule shell (these capsules are not currently being marketed)
  • Tablets: 500 mg ()
  • Capsules: 200 mg (not currently being marketed) ()
  • INVIRASE/ritonavir is contraindicated in patients with congenital long QT syndrome, those with refractory hypokalemia or hypomagnesemia, and in combination with drugs that both increase saquinavir plasma concentrations and prolong the QT interval .
  • INVIRASE/ritonavir is contraindicated in patients with complete atrioventricular (AV) block without implanted pacemakers, or patients who are at high risk of complete AV block .
  • INVIRASE/ritonavir is contraindicated in patients with clinically significant hypersensitivity (e.g., anaphylactic reaction, Stevens-Johnson syndrome) to saquinavir, saquinavir mesylate, or any of its ingredients.
  • INVIRASE/ ritonavir is contraindicated in patients with severe hepatic impairment.
  • INVIRASE/ritonavir is contraindicated with drugs that are CYP3A substrates for which increased plasma levels may result in serious or life-threatening reactions .
  • INVIRASE/ritonavir is contraindicated in patients receiving the following co-administered drugs; however, it should be noted that this list is not intended to be exhaustiven
  • INVIRASE/ritonavir is contraindicated in patients with congenital or documented acquired QT prolongation, patients with refractory hypokalemia or hypomagnesemia, or those on concomitant therapy with other drugs that prolong the QT interval. ()
  • INVIRASE is contraindicated in patients with complete atrioventricular (AV) block without implanted pacemakers, or patients who are at high risk of complete AV block. ()
  • INVIRASE is contraindicated in patients with clinically significant hypersensitivity (e.g., anaphylactic reaction, Stevens-Johnson syndrome) to saquinavir, saquinavir mesylate, or any of its ingredients. ()
  • INVIRASE/ritonavir is contraindicated in patients with severe hepatic impairment. ()
  • INVIRASE/ritonavir is contraindicated with CYP3A substrates for which increased plasma levels may result in serious or life-threatening reactions. ()
  • INVIRASE/ritonavir is contraindicated to be coadministered with rifampin due to the risk of severe hepatotoxicity. ()
  • No data
  • INVIRASE must be used in combination with ritonavir. Cobicistat is not interchangeable with ritonavir and is not recommended for use in combination with INVIRASE. ()
  • The concomitant use of INVIRASE/ritonavir and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. (, )
  • QT and PR interval prolongations have been observed in a healthy volunteer study. Use with caution in patients with preexisting conduction system abnormalities and certain heart diseases. (, , )
  • Patients on INVIRASE therapy may develop new onset or exacerbations of diabetes mellitus (), hyperglycemia (), elevated cholesterol and/or triglyceride concentrations (), redistribution/accumulation of body fat (), and immune reconstitution syndrome (). Monitor cholesterol and triglycerides prior to therapy and periodically thereafter. ()
  • In patients with underlying hepatitis B or C, cirrhosis, chronic alcoholism and/or other underlying liver abnormalities there have been reports of worsening liver disease. ()
  • Hemophilia: Spontaneous bleeding may occur and additional factor VIII may be required. ()
  • Each tablet contains lactose monohydrate. INVIRASE is not recommended in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. ()
  • Various degrees of cross-resistance have been observed. ()
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • The most common adverse reactions are nausea, vomiting, diarrhea, fatigue, pneumonia, lipodystrophy and abdominal pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or .
  • Drug interaction studies have been completed with INVIRASE and saquinavir mesylate capsules (hard gel and soft gel). Observations from drug interaction studies with saquinavir mesylate capsules (soft gel) may not be predictive for INVIRASE/ritonavir.
  • INVIRASE/ritonavir is a potent inhibitor of CYP3A, significantly increasing the exposure of drugs primarily metabolized by CYP3A. ()
  • Coadministration of INVIRASE/ritonavir with drugs that induce CYP3A may result in decreased plasma concentrations of saquinavir and reduced efficacy. ()
  • Certain drugs or drug classes should not be coadministered with INVIRASE/ritonavir based on drug interaction studies or predicted drug interactions. (, , )
  • No data
  • Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. ()
  • Lactation: Breastfeeding is not recommended due to risk of HIV-1 transmission. ()
  • Geriatric Use: Caution should be exercised due to greater frequency of decreased hepatic, renal or cardiac function in elderly population. ()
  • There is limited experience of overdose with saquinavir.
  • No acute toxicities or sequelae were noted in one subject who ingested 8 grams of INVIRASE as a single dose. The subject was treated with induction of emesis within 2 to 4 hours after ingestion. A second subject ingested 2.4 grams of INVIRASE in combination with 600 mg of ritonavir and experienced pain in the throat that lasted for 6 hours and then resolved. In an exploratory Phase II study of oral dosing with INVIRASE at 7,200 mg per day (1,200 mg q4h), there were no serious toxicities reported through the first 25 weeks of treatment.
  • Treatment of overdose with saquinavir should consist of general supportive measures, including monitoring of vital signs and ECG and observations of the patient's clinical status. Since saquinavir is highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substance.
  • INVIRASE brand of saquinavir mesylate is an inhibitor of the human immunodeficiency virus type 1 (HIV-1) protease.
  • The chemical name for saquinavir mesylate is N-tert-butyl-decahydro-2-[2(R)-hydroxy-4-phenyl-3(S)-[[N-(2-quinolylcarbonyl)-L-asparaginyl]amino]butyl]-(4aS,8aS)-isoquinoline-3(S)-carboxamide methanesulfonate with a molecular formula CHNOu2219CHOS and a molecular weight of 766.96. The molecular weight of the free base is 670.86. Saquinavir mesylate has the following structural formula:
  • Saquinavir mesylate is a white to off-white, very fine powder with an aqueous solubility of 2.22 mg per mL at 25u00b0C.
  • INVIRASE tablets are available as light orange to greyish- or brownish-orange, oval cylindrical, biconvex film-coated tablet for oral administration in 500-mg strength (as saquinavir free base). Each tablet also contains the inactive ingredients lactose, microcrystalline cellulose, povidone K30, croscarmellose sodium, and magnesium stearate. Each film coat contains hypromellose, titanium dioxide, talc, iron oxide yellow, iron oxide red, and triacetin.
  • Saquinavir mesylate capsules (hard gel) are light brown and green, opaque hard gelatin capsules for oral use in a 200-mg strength (as saquinavir free base) []. Each capsule also contains the inactive ingredients lactose, microcrystalline cellulose, povidone K30, sodium starch glycolate, talc, and magnesium stearate. Each capsule shell contains gelatin and water with the following dye systems: red iron oxide, yellow iron oxide, black iron oxide, FD&C Blue #2, and titanium dioxide. These capsules are not currently being marketed.
  • No data
  • No data
  • In a randomized, double-blind clinical study NV14256 in zidovudine-experienced, HIV-1-infected adult subjects, saquinavir mesylate capsules (hard gel) in combination with zalcitabine was shown to be superior to monotherapy with either saquinavir mesylate capsules (hard gel) or zalcitabine in decreasing the cumulative incidence of clinical disease progression to AIDS-defining events or death. In another randomized study ACTG229/NV14255, subjects with advanced HIV-1 infection with history of prolonged zidovudine treatment were administered saquinavir mesylate capsules (hard gel) 600 mg (three times daily) + zidovudine + zalcitabine. Subjects receiving this regimen experienced greater increases in CD4 cell counts as compared to those who received saquinavir mesylate capsules (hard gel) + zidovudine or zalcitabine + zidovudine. It should be noted the HIV treatment regimens that were used in these clinical trials are no longer considered standard of care.
  • In the MaxCmin1 trial, saquinavir gel capsule 1,000 mg twice daily coadministered with ritonavir 100 mg twice daily was evaluated in a heterogeneous population of 148 HIV-1-infected subjects. A total of 42 subjects enrolled were treatment nau00efve, and 106 subjects were treatment experienced (of which 52 subjects had HIV-1 RNA < 400 copies/mL at baseline). Results showed that 91/148 (61%) subjects achieved and/or sustained an HIV-1 RNA < 400 copies per mL at the completion of 48 weeks of treatment.
  • INVIRASE 500-mg film-coated tablets are light orange to greyish or brownish orange, oval cylindrical, biconvex tablets with ROCHE and SQV 500 imprinted on the tablet faceu2014bottles of 120 (NDC 0004-0244-51). INVIRASE tablets should be stored at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature] in tightly closed bottles.
  • Saquinavir mesylate capsules (hard gel) 200-mg are light brown and green opaque capsules with ROCHE and 0245 imprinted on the capsule shellu2014bottles of 270 (NDC 0004-0245-15). Saquinavir mesylate capsules (hard gel) should be stored at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature] in tightly closed bottles. Saquinavir mesylate capsules (hard gel) are not currently being marketed.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Representative sample of labeling (see the section for complete listing):
  • PRINCIPAL DISPLAY PANEL - 200 mg Capsule Bottle Label
  • NDC 0004-0245-15
  • Invirase
  • 200 mg
  • Each capsule contains saquinavir mesylate equivalent to 200 mg saquinavir (free base).
  • ALERT: Find out about medicines that should NOT be taken with INVIRASE.
  • Rx only
  • Attention Pharmacist: Dispense the enclosed Medication Guide to each patient. Do not cover ALERT box with pharmacy label.
  • 270 capsules
  • Genentech
  • 10172943
  • NDC 0004-0244-51
  • Invirase
  • 500 mg
  • Each tablet contains saquinavir mesylate equivalent to 500 mg saquinavir (free base).
  • ALERT: Find out about medicines that should NOT be taken with INVIRASE.
  • Rx only
  • Attention Pharmacist: Dispense the enclosed Medication Guide to each patient. Do not cover ALERT box with pharmacy label.
  • 120 tablets
  • Genentech
  • 10172487

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