LOMUSTINE
Generic: LOMUSTINE
Basic Information
Manufacturer
Carnegie Pharmaceuticals LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
916dfac8-da11-40e4-9e44-a909e29a6b5f
Indications & Usage
1 INDICATIONS AND USAGE Lomustine Capsules are an alkylating drug indicated for the treatment of patients with: Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures.
(1) Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy.
(1) 1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
1.2 Hodgkin’s Lymphoma Lomustine Capsules are indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin’s lymphoma whose disease has progressed following initial chemotherapy.
1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
1.2 Hodgkin’s Lymphoma Lomustine Capsules are indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin’s lymphoma whose disease has progressed following initial chemotherapy.
(1) Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy.
(1) 1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
1.2 Hodgkin’s Lymphoma Lomustine Capsules are indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin’s lymphoma whose disease has progressed following initial chemotherapy.
1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
1.2 Hodgkin’s Lymphoma Lomustine Capsules are indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin’s lymphoma whose disease has progressed following initial chemotherapy.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Delayed myelosuppression [see Warnings and Precautions (5.1) ] Risks of overdosage [see Warnings and Precautions (5.2) ] Pulmonary toxicity [see Warnings and Precautions (5.3) ] Secondary malignancies [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Nephrotoxicity [see Warnings and Precautions (5.6) ] The following adverse reactions associated with the use of Lomustine Capsules were identified in clinical trials or postmarketing reports.
Because these reactions were reported from a population of uncertain size, it is not possible to estimate their frequency, reliability, or establish a causal relationship to drug exposure.
Gastrointestinal disorders: nausea, vomiting, and stomatitis Ocular disorders: optic atrophy, visual disturbances, and blindness Neurologic disorders: disorientation, lethargy, ataxia, and dysarthria Other: alopecia Common adverse reactions include delayed myelosupression, nausea, vomiting, stomatitis, and alopecia.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Carnegie Pharmaceuticals LLC at 1-732-783-7010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Because these reactions were reported from a population of uncertain size, it is not possible to estimate their frequency, reliability, or establish a causal relationship to drug exposure.
Gastrointestinal disorders: nausea, vomiting, and stomatitis Ocular disorders: optic atrophy, visual disturbances, and blindness Neurologic disorders: disorientation, lethargy, ataxia, and dysarthria Other: alopecia Common adverse reactions include delayed myelosupression, nausea, vomiting, stomatitis, and alopecia.
(6) To report SUSPECTED ADVERSE REACTIONS, contact Carnegie Pharmaceuticals LLC at 1-732-783-7010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .