Temozolomide 180 mg/1
Temozolomide · CAPSULE · CivicaScript LLC
Temozolomide is a capsule containing temozolomide at 180 mg/1, taken oral. Manufactured by CivicaScript LLC.
Key Facts
- Brand Name
- Temozolomide
- Generic Name
- Temozolomide
- NDC Code (Product)
82249-412- Manufacturer
- CivicaScript LLC
- Strength
- 180 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207658
- Drug Class
- Alkylating Drug [EPC]
- Marketing Start
- 04/28/2017
Recall History
Amerigen Pharmaceuticals Inc.
Failed dissolution specifications
Rising Pharma Holding, Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Mylan LLC.
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Mylan LLC.
Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Amerigen Pharmaceuticals Inc.
Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
Schering-Plough Products, LLC
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Deva Holding AS - Cerkezkoy Subesi
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE TEMOZOLOMIDE Capsules are an alkylating drug indicated for the treatment of adult patients with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) Anaplastic astrocytoma ( 1.2 ) Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2 ) Treatment of adults with refractory anaplastic astrocytoma. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMOZOLOMIDE Capsules is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.2 Anaplastic Astrocytoma TEMOZOLOMIDE Capsules is indicated for the: adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma; treatment of adults with refractory anaplastic astrocytoma.
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Administer either orally or intravenously. (2.4) Newly Diagnosed Glioblastoma: 75 mg/m 2 once daily for 42 to 49 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m 2 once daily for Days 1 to 5 of each 28-day cycle for 6 cycles. May increase maintenance dose to 200 mg/ m 2 for cycles 2 – 6 based on toxicity. ( 2.1 ) Provide Pneumocystis pneumonia (PCP) prophylaxis during concomitant phase and continue in patients who develop lymphopenia until resolution to grade 1 or less. ( 2.1 ) Adjuvant Treatment of Newly Diagnosed Anaplastic Astrocytoma: Beginning 4 weeks after the end of radiotherapy, administer TEMOZOLOMIDE Capsules orally in a single dose on days 1-5 of a 28-day cycle for 12 cycles. The recommended dosage for Cycle 1 is 150 mg/m 2 per day and for Cycles 2 to 12 is 200 mg/m 2 if patient experienced no or minimal toxicity in Cycle 1. ( 2.2 ) Refractory Anaplastic Astrocytoma : Initial dose of 150 mg/m 2 once daily on Days 1 to 5 of each 28-day cycle. ( 2.2 ) 2.1 Monitoring to Inform Dosage and Administration Prior to dosing, withhold TEMOZOLOMIDE until patients have an absolute neutrophil count (ANC) of 1.5 x 1…
Contraindications
4. CONTRAINDICATIONS TEMOZOLOMIDE is contraindicated in patients with a history of hypersensitivity reactions to: • temozolomide or any other ingredients in TEMOZOLOMIDE; and • dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide. Reactions to TEMOZOLOMIDE have included anaphylaxis [see Adverse Reactions ( 6.2 )]. History of hypersensitivity to temozolomide or any other ingredients in TEMOZOLOMIDE capsules and dacarbazine. ( 4 )
Adverse Reactions
6. ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )]. Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. Pneumocystis Pneumonia [see Warnings and Precautions ( 5.3 )]. Secondary Malignancies [see Warnings and Precautions ( 5.4 )]. The most common adverse reactions (≥ 20% incidence) are: alopecia, fatigue, nausea, vomiting, headache, constipation, anorexia, and convulsions. ( 6.1 ) The most common Grade 3 to 4 hematologic laboratory abnormalities (≥ 10% incidence) in patients with anaplastic astrocytoma are: decreased lymphocytes, decreased platelets, decreased neutrophils, and decreased leukocytes.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Devatis Inc. at 1-833-534-4406 or druginfo@devatis.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or www.devatis.com. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practic…
Frequently Asked Questions
What is Temozolomide used for?
Temozolomide contains Temozolomide. It is a capsule taken oral. Consult your doctor for specific uses.
Is Temozolomide a controlled substance?
Temozolomide is not classified as a controlled substance by the DEA.
What is the generic name for Temozolomide?
The generic name for Temozolomide is Temozolomide. There are 2 other brand versions of Temozolomide.
What is the NDC code for Temozolomide 180 mg/1?
The NDC (National Drug Code) for Temozolomide 180 mg/1 is 82249-412, listed by CivicaScript LLC.