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Material Safety Data Sheet: Paxlovid

Identification

Product Name: Paxlovid
Synonyms: Nirmatrelvir tablets; Ritonavir tablets
Manufacturer: Pfizer Inc.
Intended Use: Antiviral medication for treating COVID-19
Contact Information: Pfizer Medical Information, 1-800-438-1985
Emergency Telephone: CHEMTREC, +1 703-527-3887 (International)

Hazard Identification

Classification: Acute toxicity (oral), Specific Target Organ Toxicity (single exposure), Reproductive toxicity
Signal Word: Warning
Hazard Statements: May cause liver and kidney effects; May cause allergic skin reactions; May affect reproductive system upon repeated exposure
Precautionary Statements: Avoid inhalation, ingestion, or contact with skin and eyes; Wear appropriate protective clothing; Practice good industrial hygiene;
Pictograms: Exclamation mark, Health hazard

Composition / Information on Ingredients

Nirmatrelvir: CAS Number: 2628280-40-8, ~150 mg/tablet
Ritonavir: CAS Number: 155213-67-5, ~100 mg/tablet
Inactive Ingredients: Colloidal silicon dioxide, microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, magnesium stearate, lactose monohydrate, titanium dioxide, hypromellose, polyethylene glycol, iron oxides (yellow/red)
Concentration of Actives: Varies by regimen as prescribed

First Aid Measures

Inhalation: Move to fresh air; seek medical attention if symptoms persist
Skin Contact: Wash thoroughly with soap and water; remove contaminated clothing; seek medical help if irritation develops
Eye Contact: Rinse immediately with plenty of water for at least 15 minutes; consult physician
Ingestion: Do not induce vomiting; drink water; call poison control and seek medical guidance immediately

Fire-Fighting Measures

Suitable Extinguishing Media: Dry chemical, CO2, foam, water spray
Special Hazards: Emits toxic fumes under fire conditions; Risk of dust explosion in powder form
Protective Equipment: Firefighters should wear full protective gear, positive pressure self-contained breathing apparatus
Hazardous Combustion Products: Carbon oxides, nitrogen oxides, sulfur oxides

Accidental Release Measures

Personal Precautions: Use personal protective equipment; Prevent dust formation; Ensure adequate ventilation
Environmental Precautions: Avoid discharge into drains, water courses, soil
Methods for Cleanup: Sweep up without creating dust; Use damp cloth to wipe residues; Place in secure closed containers for disposal

Handling and Storage

Handling: Avoid creating dust; Handle in well-ventilated areas; Wash hands after handling; No instrumentation or eating in working area
Storage: Store in original packaging; Keep tightly closed and dry; Maintain at 20–25°C (68–77°F); Protect from light, moisture

Exposure Controls and Personal Protection

Engineering Controls: Use pharmaceutical-grade handling methods; Local exhaust ventilation
Personal Protective Equipment: Gloves (nitrile or latex), lab coat, safety goggles
Respiratory Protection: Approved respirators if dust formation likely
Hygiene Measures: Wash hands thoroughly after use; Remove contaminated clothing and wash before reuse

Physical and Chemical Properties

Form: Film-coated tablet
Appearance: Nirmatrelvir tablets: Pink, oval; Ritonavir tablets: White or off-white
Odor: Odorless or nearly odorless
pH: Not determined
Solubility: Moderate in aqueous media
Melting Point: Not available commercially as single compounds
Partition Coefficient: LogP estimates for actives: Nirmatrelvir 1.3; Ritonavir 3.0
Boiling Point: Not applicable for solid oral dosage forms
Flash Point: Not determined

Stability and Reactivity

Chemical Stability: Stable under recommended storage conditions
Hazardous Reactions: Unlikely under normal handling
Conditions to Avoid: Exposure to light, moisture, excessive heat or freezing
Materials to Avoid: Strong oxidizing agents
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, sulfur oxides

Toxicological Information

Acute Toxicity: Low toxicity expected at prescribed doses, but risk of adverse effects increases in overdose
Chronic Effects: May affect liver enzymes (ALT, AST); Known to interact with CYP450 substrates, inducers, inhibitors
Carcinogenicity: Not classified as carcinogenic by IARC, NTP, or OSHA
Reproductive Toxicity: Animal studies suggest possible developmental toxicity at high dose exposure
Sensitization: May cause allergic skin reactions in sensitive individuals
Symptoms of Overexposure: Nausea, diarrhea, headache, increase in liver enzymes, potential renal effects

Ecological Information

Ecotoxicity: Nirmatrelvir and ritonavir show some toxicity to aquatic organisms; Bioaccumulation potential considered low to moderate
Persistence and Degradability: Active ingredients may persist in the environment if released in significant quantities
Mobility: Tablets are not highly mobile in soil or water; powders disperse more easily
Other Adverse Effects: Limited data on effects to terrestrial wildlife

Disposal Considerations

Waste Treatment Methods: Collect as pharmaceutical waste; Do not dispose of with household garbage
Disposal Containers: Use sealed, labeled containers as per pharmaceutical protocols
Regulations: Disposal must comply with federal, state, local, and institutional regulations
Special Instructions: Do not flush tablets down the toilet or pour down drains
Unused Product Return: Return unused medicine to take-back programs or through pharmacy-based disposal

Transport Information

UN Number: Not regulated as hazardous for transportation (IATA, ADR, DOT)
Proper Shipping Name: Pharmaceuticals, solid, n.o.s.
Transport Hazard Class: Not applicable
Packing Group: Not applicable
Special Precautions: Keep packaging intact and dry during shipping; Avoid extreme temperatures

Regulatory Information

Regulatory Status: Approved for emergency or conditional use by health authorities including FDA, EMA
OSHA Status: Not considered hazardous under OSHA criteria
TSCA: Components not listed for commercial chemical use
REACH: Not applicable for finished pharmaceutical products
Other Information: Subject to prescription drug guidelines, and pharmacy dispensing regulations; Report accidental exposures to relevant health authorities