Revlimid

Hazard statements (CLP)

H351, H360D, H372

Code

Statements

H351

Suspected of causing cancer

SECTION 2: Hazards identification

WHMIS 2015 Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labelling listed below is for bulk Revlimid Capsules Globally Harmonized System [GHS] Specific Target Organ Toxicity (repeated exposure) - Category 1. Reproductive Toxicity - Category 1B. Carcinogenic - Category 2

2.2 Label elements

SECTION 2 - HAZARDS IDENTIFICATION …continued

Signal word

Danger

Hazard statements

H360D - May damage the unborn child. H372 - Causes damage to hematopoietic system through prolonged or repeated exposure. H351 - Suspected of causing cancer. Wash hands thoroughly after handling. P270 - Do not eat, drink or smoke when using this product. P281 - Use personal protective equipment as required. P308 + P313 - If exposed or concerned: get medical advice/attention. P405 - Store locked up. P501 - Dispose of contents/container to location in accordance with local/ regional/national/international regulations.

Precautionary statements

P201 - Obtain special instructions before use. P260 - Do not breathe dust. P264 -

2.3 Other hazards

Severe hematological toxicity (including neutropenia and thrombocytopenia) occurs in patients taking 10 mg/day. The other most commonly observed adverse events associated with therapeutic use of lenalidomide include gastrointestinal disturbances, increased tendency for infections, vascular disorders (including potentially dangerous blood clots), itchiness, rash, anemia and fatigue. No human studies of pregnancy outcomes after exposure to lenalidomide have been conducted. However, because it is an analog of thalidomide (a known human teratogen) and is teratogenic in monkeys at low doses, lenalidomide is considered a probable human developmental toxicant. There is an increased risk of second primary malignancies (SPMs) in certain cancer patients treated with lenalidomide in combination with other chemotherapeutics as observed in clinical trials. Although some were determined to be associated with the initial drug treatment, the cancer risk of lenalidomide cannot be completely ruled out. Note This mixture is classified as hazardous under GHS as implemented by Regulation

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to substance or mixture