Advise the patient to read the FDA-approved patient labeling (Patient Information).
Embryo-Fetal Toxicity
Hypersensitivity Reactions
Advise patients of the potential risk of hypersensitivity and that Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity to methotrexate. Advise patients to seek immediate medical attention if signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.2)].
Myelosuppression and Serious Infections
Advise patient to contact their healthcare provider immediately for new onset fever, symptoms of infection, easy bruising or persistent bleeding [see Warnings and Precautions (5.4, 5.5)].
Renal Toxicity
Advise patients that methotrexate can cause renal toxicity. Advise patients to immediately contact their healthcare provider for signs or symptoms of renal toxicity, such as marked increases or decreases in urinary output [see Warnings and Precautions (5.6)].
Hepatotoxicity
Advise patients to report signs or symptoms of hepatic toxicity and avoidance of alcohol during methotrexate treatment [see Warnings and Precautions (5.7)].
Neurotoxicity
Advise patient to contact their healthcare provider immediately if they develop new neurological symptoms [see Warnings and Precautions (5.8)].
Gastrointestinal Toxicity
Advise patients to contact their healthcare provider if they develop diarrhea, vomiting, or stomatitis. Advise patients to immediately contact their healthcare provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, hematemesis, or melena [see Warnings and Precautions (5.9)].
Pulmonary Toxicity
Advise patients to contact their healthcare provider for symptoms of cough, fever, and dyspnea [see Warnings and Precautions (5.10)].
Dermatologic Toxicity
Advise patients that Methotrexate Injection can cause serious skin rash and to immediately contact their healthcare provider for new or worsening skin rash. Advise patients to avoid excessive sun exposure and to use sun protection measures [see Warnings and Precautions (5.11)].
Secondary Malignancies
Advise patients on the risk of second primary malignancies during treatment with Methotrexate Injection [see Warnings and Precautions (5.13)].
Lactation
Advise women not to breastfeed during treatment with Methotrexate Injection and for 1 week after the last dose [see Use in Specific Populations (8.2)].
Infertility
Advise females and males of reproductive potential that Methotrexate Injection may cause impairment of fertility [see Use in Specific Populations (8.3)].
Drug Interactions
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