Methotrexate for Injection, USP

Signal word

DANGER. GHS Class: Acute Oral Toxicity. Category 3. Serious Eye Damage. Category 1. Skin corrosion. Category 1. Reproductive toxicity. Category 1A. Skin Sensitization. Category 1. Specific Target Organ Toxicity - STOT, Single Exposure SE. Category 3. Reproductive toxicity. Effects on or via lactation.

Hazard statements

Toxic if swallowed. Causes serious eye damage. Causes severe skin burns and eye damage. May damage fertility or the unborn child. May cause an allergic skin reaction. May cause respiratory irritation. May cause harm to breast-fed children.

Precautionary statements

Obtain special instructions before use. Do not handle until all safety precautions have been read and understood. Do not breathe dust/fume/gas/mist/vapours/spray. Avoid breathing dust/fume/gas/mist/vapours/spray. Avoid contact during pregnancy and while nursing. Wash hands thoroughly after handling. Do not eat, drink or smoke when using this product. Use only outdoors or in a well-ventilated area. Contaminated work clothing should not be allowed out of the workplace. Wear protective gloves/protective clothing/eye protection/face protection. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician IF SWALLOWED: Rinse mouth. Do not induce vomiting. IF ON SKIN: Wash with plenty of water. IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF exposed or concerned: Get medical advice/attention. Immediately call a POISON CENTER or doctor/physician. Call a POISON CENTER or doctor/physician if you feel unwell. Specific treatment (see ... on this label). Rinse mouth. If skin irritation or rash occurs: Get medical advice/attention. Take off contaminated clothing and wash it before reuse. Wash contaminated clothing before reuse. Store in a well-ventilated place. Keep container tightly closed. Store locked up. Dispose of contents/container in accordance with Local, State, Federal and Provincial regulations. Emergency Overview: This product is intended for therapeutic use only when prescribed by a physician. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.

Principle Routes of Exposure

Inhalation Ingestion Eye contact Skin Absorption. Injection.

Potential health effects

Methotrexate may cause cancer and may be mutagenic, teratogenic, and fetotoxic. Eye: Contact with eyes may cause irritation.

Potential chronic health

Chronic exposure may cause hepatotoxicity, fibrosis, and cirrhosis. Signs/Symptoms: Possible adverse reactions are related to the dose and frequency of administration and may include: hepatotoxicity, methotrexate-induced lung disease, diarrhea, ulcerative stomatitis, malignant lymphomas, anemia, leukopenia, nausea, and abdominal distress. Inhalation of methotrexate may cause GI disturbances: nausea, vomiting, loss of appetite, diarrhea, and congestion of the lungs and cough. Bone marrow suppression and liver damage may also be seen. Severe, occasionally fatal skin reactions have been reported following single or multiple doses of methotrexate. Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with methotrexate therapy. Other frequently reported adverse effects are malaise, fatigue, chills, fever, dizziness, and decreased resistance to infection. See the package insert for more information. Occupational exposure has not been fully investigated. Aggravation of Pre-Existing Methotrexate can affect the bone marrow, liver, lungs, and kidneys. Methotrexate elimination is Conditions: reduced in patients with impaired renal function, ascites, or pleural effusion.