POMALYST ; IMNOVID

Hazard statements (CLP)

H351, H360D, H373

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 POMALYST/ IMNOVID capsules HAZARDS IDENTIFICATION …continued Globally Harmonized System [GHS] Specific Target Organ Toxicity (repeated exposure) - Category 2 (hematological, neurological, and gastrointestinal organs)., Reproductive Toxicity - Category 1B Carcinogenic - Category 2

Signal word

Danger

Hazard statements

H360D - May damage the unborn child. H373 - May cause damage to hematological, neurological and gastrointestinal systems through prolonged or repeated exposure. H351 - Suspected of causing cancer. 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. P281 -

2.3 Other hazards

The most commonly reported effects in clinical trials with pomalidomide include potentially severe hematological toxicity (e.g., neutropenia, thrombocytopenia, anemia), rash, constipation, fatigue, muscle pain, paresthesia, peripheral edema, fever, dizziness and headache. It may also be associated with an increased risk of thrombotic events. No human studies of pregnancy outcomes after exposure to pomalidomide were identified. However, because it is an analogue of thalidomide (a known human teratogen), causes embryo/fetotoxicity in rats, and is teratogenic to both rats and rabbits, pomalidomide is considered a probable human developmental toxicant. An increased incidence of second primary malignancies (SPMs) was seen in certain cancer patients treated with pomalidomide in combination with a corticosteroid in comparison to the corticosteroid alone. Although SPM rates were low overall, the data suggest that a potential for pomalidomide to increase neoplasms cannot be excluded if accidental exposure occurs. 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