Note: Ingredients listed on restricted chemical lists
General Information
Revision date
2015-02-17
Product name
Letairis , Volibris
Product Synonyms
(S)-2-(4,6-dimethyl-pyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid
1.2.1 Relevant identified uses
Endothelin receptor antagonist approved for the treatment of pulmonary arterial hypertension (PAH), to improve exercise ability and delay clinical worsening
Emergency telephone
Canada
Icons in SDS
Company Information
company name
Gilead Sciences, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
msdscoordinator@gilead.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H360DF
Section 2
2.1 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 drug product. Regulation (EC) Reproductive Toxicity - Category 1B. 1272/2008 [GHS] Directive 67/548/EEC or T - R61 (Repr. Cat 2) 1999/45/EC
2.2 Label elements
SECTION 2 - HAZARDS IDENTIFICATION …continued
Signal word
Danger Warning US Hazard overview Pharmaceutical product for prescription use only. If tablets are crushed or broken and contacted, exposure may occur. Possible reproductive/developmental hazard - contains ambrisentan, an endothelin receptor antagonist which may cause adverse reproductive effects or may adversely affect the developing fetus. Note This product/mixture is classified as hazardous according to Directive 1999/45/EC, Regulation EC No 1272/2008 (EU-CLP), and applicable US regulations. The CLP/ GHS classifications are based on Regulation (EC) 1272/2008.
CLP CLASSIFICATION
H360DF - May damage fertility or the unborn child.
Hazard statements
CLP/GHS precautionary P201 - Obtain special instructions before use. P202 - Do not handle until all safety precautions have been read and understood. 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. EU symbol/indication of danger T- Toxic. Risk (R) Phrase(s) R60 - May impair fertility. R61 - May cause harm to the unborn child.
Precautionary statements
S2 - Keep out of reach of children. S13 - Keep away from food, drink, and animal feeding stuffs. S22 - Do not breathe dust. S24/25 - Avoid contact with skin and eyes. S36 - Wear suitable protective clothing. S53 - Avoid exposure - Obtain special instructions before use.
2.3 Other hazards
In human clinical use, the most frequently reported adverse effects following repeat dose in healthy individuals included headache, fatigue, dizziness, feeling hot, photophobia, and nasal congestion. There may be a drug-related decrease in blood hemoglobin concentrations associated with chronic use. Frequently reported adverse effects in PAH patients included: peripheral edema, nasal congestion, sinusitis, flushing, nasopharyngitis, abdominal pain, constipation, palpitations, dyspnea, and headache. Decreased sperm counts have also been observed in human and animal studies with other endothelin receptor antagonists.
