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Temozolomide (Temozolomide)

Trade Name : Temozolomide

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 5 mg/1

TEMOZOLOMIDE Alkylating Activity [MoA],Alkylating Drug [EPC]

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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 Temozolomide (Temozolomide) which is also known as Temozolomide and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 5 mg/1 per ml. Read more

Temozolomide (Temozolomide) 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

Packaging and Delivery

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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.

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About GNH

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
  • Temozolomide capsules are an alkylating drug indicated for the treatment of adult patients with:
  • Newly diagnosed glioblastoma multiforme (GBM) concomitantly with radiotherapy and then as maintenance treatment. ()
  • Refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. ()
  • No data
  • Newly Diagnosed GBM: 75 mg/m for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m once daily for Days 1 to 5 of a 28-day cycle of temozolomide for 6 cycles. ()
  • Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m once daily for 5 consecutive days per 28-day treatment cycle. ()
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  • 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg capsules. ()
  • Temozolomide is contraindicated in patients who have a history of hypersensitivity reaction (such as urticaria, allergic reaction including anaphylaxis, toxic epidermal necrolysis, and Stevens-Johnson syndrome) to any of its components. Temozolomide is also contraindicated in patients who have a history of hypersensitivity to dacarbazine (DTIC), since both drugs are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC).
  • Known hypersensitivity to any temozolomide capsules component or to dacarbazine (DTIC). ()
  • No data
  • Myelosuppression - monitor Absolute Neutrophil Count (ANC) and platelet count prior to dosing and throughout treatment. Geriatric patients and women have a higher risk of developing myelosuppression. ()
  • Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukemia, have been observed. ()
  • Pneumocystis
  • All patients, particularly those receiving steroids, should be observed closely for the development of lymphopenia and PCP. ()
  • Complete blood counts should be obtained throughout the treatment course as specified. ()
  • Hepatotoxicity fatal and severe hepatotoxicity have been reported. Perform liver function tests at baseline, midway through the first cycle, prior to each subsequent cycle, and approximately two to four weeks after the last dose of temozolomide. ()
  • Fetal harm can occur when administered to a pregnant woman. Women should be advised to avoid becoming pregnant when receiving temozolomide. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or .
  • The most common adverse reactions (u2265 10% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, convulsions, rash, hemiparesis, diarrhea, asthenia, fever, dizziness, coordination abnormal, viral infection, amnesia, and insomnia. ()
  • The most common Grade 3 to 4 hematologic laboratory abnormalities (u2265 10% incidence) that have developed during treatment with temozolomide are: lymphopenia, thrombocytopenia, neutropenia, and leukopenia. ()
  • Allergic reactions have also been reported. ()
  • Administration of valproic acid decreases oral clearance of temozolomide by about 5%. The clinical implication of this effect is not known .
  • Valproic acid: decreases oral clearance of temozolomide. ()
  • No data
  • Nursing mothers: Not recommended. ()
  • Pediatric use: No established use. ()
  • Hepatic/Renal Impairment: Caution should be exercised when temozolomide is administered to patients with severe renal or hepatic impairment. (, )
  • Doses of 500, 750, 1000, and 1250 mg/m (total dose per cycle over 5 days) have been evaluated clinically in patients. Dose-limiting toxicity was hematologic and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure, and death. There are reports of patients who have taken more than 5 days of treatment (up to 64 days), with adverse reactions reported including bone marrow suppression, which in some cases was severe and prolonged, and infections and resulted in death. In the event of an overdose, hematologic evaluation is needed. Supportive measures should be provided as necessary.
  • Temozolomide Capsules contain temozolomide, USP, an imidazotetrazine derivative. The chemical name of temozolomide, USP is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-s-tetrazine-8-carboxamide. The structural formula is:
  • CHNO M.W. 194.15
  • The material is a white to light tan/light pink powder. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide, USP can be administered orally. The prodrug, temozolomide, USP, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH.
  • Each capsule contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients for Temozolomide Capsules are anhydrous lactose, colloidal silicon dioxide, povidone, sodium starch glycolate, stearic acid, and tartaric acid. The 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg capsule shells contain D&C yellow no. 10, FD&C red no. 40, FD&C yellow no. 6, gelatin, and titanium dioxide. The 140 mg capsule shell also contains D&C red no. 28, FD&C blue no. 1, and FD&C green no. 3. The 180 mg capsule shell also contains FD&C blue no. 1. The 5 mg imprinting ink contains ammonium hydroxide, black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, propylene glycol, and shellac. The 20 mg imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol, red iron oxide, shellac, and yellow iron oxide. The 100 mg imprinting ink contains FD&C blue no. 1 aluminum lake, polyvinylpyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. The 140 mg, 180 mg, and 250 mg imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol, and shellac.
  • No data
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  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Physicians should discuss the following with their patients:
  • TEVA PHARMACEUTICALS USA, INC.
  • Rev. H 10/2017
  • TEMOZOLOMIDE (tem-oh zoe-loe-mide)
  • Capsules
  • PHARMACIST
  • Rx only
  • PHARMACIST INFORMATION SHEET
  • TEMOZOLOMIDE (tem-oh zoe-loe-mide)n- Capsules
  • Rx only
  • What is the most important information I should know about temozolomide?
  • See the section u201cWhat are the possible side effects of temozolomide?u201d for more information about side effects.
  • What is temozolomide?
  • Temozolomide is a prescription medicine used to treat adults with certain brain cancer tumors. Temozolomide blocks cell growth, especially cells that grow fast, such as cancer cells. Temozolomide may decrease the size of certain brain tumors in some patients.
  • It is not known if temozolomide is safe and effective in children.
  • Who should not take temozolomide?
  • Do not take temozolomide if you:
  • What should I tell my doctor before taking temozolomide?
  • Tell your doctor about all your medical conditions, including if you:
  • Tell your doctor about all the medicines you take,
  • Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
  • How should I take temozolomide?
  • Temozolomide may be taken by mouth as a capsule at home.
  • There are two common dosing schedules for taking temozolomide.
  • Temozolomide Capsules
  • What should I avoid while taking temozolomide?
  • What are the possible side effects of temozolomide?
  • Temozolomide can cause serious side effects.
  • Your doctor will check your blood regularly while you are taking temozolomide to see if these side effects are happening. Your doctor may need to change the dose of temozolomide or when you get it depending on your blood cell counts. People who are age 70 or older and women may be more likely to have their blood cells affected.
  • Common side effects with temozolomide include:
  • Tell your doctor about any side effect that bothers you or that does not go away.
  • These are not all the possible side effects with temozolomide. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store temozolomide capsules?
  • General information about temozolomide.
  • Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use temozolomide for a condition for which it was not prescribed. Do not give temozolomide to other people, even if they have the same symptoms that you have. It may harm them.
  • This leaflet summarizes the most important information about temozolomide. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about temozolomide that is written for health professionals.
  • For more information, call 1-888-838-2872.
  • How are temozolomide capsules supplied?
  • The 5 mg, 20 mg, 100 mg and 250 mg temozolomide capsules contain an off-white capsule body with an off-white cap. The 140 mg capsules contain an off-white capsule body with a blue cap. The 180 mg capsules contain an off-white capsule body with a dark orange cap. Each capsule contains color-coded printing or a different color cap according to strength. The capsules are available in six different strengths.
  • What are the ingredients in temozolomide?
  • Temozolomide Capsules
  • Active ingredient: temozolomide.
  • Inactive ingredients: anhydrous lactose, colloidal silicon dioxide, povidone, sodium starch glycolate, stearic acid, and tartaric acid. The 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg capsule shells contain D&C yellow no. 10, FD&C red no. 40, FD&C yellow no. 6, gelatin, and titanium dioxide. The 140 mg capsule shell also contains D&C red no. 28, FD&C blue no. 1, and FD&C green no. 3. The 180 mg capsule shell also contains FD&C blue no. 1. The 5 mg imprinting ink contains ammonium hydroxide, black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, propylene glycol, and shellac. The 20 mg imprinting ink contains ammonium hydroxide, black iron oxide, propylene glycol, red iron oxide, shellac, and yellow iron oxide. The 100 mg imprinting ink contains FD&C blue no. 1 aluminum lake, polyvinylpyrrolidone, propylene glycol, shellac, sodium hydroxide, and titanium dioxide. The 140 mg, 180 mg, and 250 mg imprinting ink contains black iron oxide, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, propylene glycol, and shellac.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • TEVA PHARMACEUTICALS USA, INC.
  • Rev. E 4/2015
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