Pomalidomide Capsules, 1 mg, 2 mg, 3 mg and 4 mg

Hazard statements (CLP)

H351, H360D, H373

Code

Statements

H351

Suspected of causing cancer

SECTION 2: Hazards identification

Hazard statements

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

Precautionary statements

P201 - Obtain special instructions before use. P260 - Do not breathe dust. P281 – Use personal protective equipment are required. P308+ P31 – 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.

2.3 Other hazards

The most commonly reported effects in clinical trials with pomalidomide include potentially severe hematological toxicity. (e.g., neutropenia, thrombocytopenia, anaemia), 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.