Contraindications : התוויות נגד

4.3       Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Medicinal products listed below are a guide and not considered a comprehensive list of all possible medicinal products that are contraindicated with Paxlovid.

Medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions.

•      Alpha1-adrenoreceptor antagonist: alfuzosin
•      Antianginal: ranolazine
•      Antiarrhythmic: dronedarone, propafenone, quinidine
•      Anticancer drugs: neratinib, venetoclax
•      Anti-gout: colchicine

      •      Antihistamines: terfenadine
•      Antipsychotics/neuroleptics: lurasidone, pimozide, quetiapine •      Benign prostatic hyperplasia medicinal products: silodosin
•      Cardiovascular medicinal products: eplerenone, ivabradine
•      Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine •      GI motility agents: cisapride
•      Immunosuppressants: voclosporin
•      Lipid-modifying agents: o HMG Co-A reductase inhibitors: lovastatin, simvastatin o Microsomal triglyceride transfer protein (MTTP) inhibitor: lomitapide •      Migraine medicinal products: eletriptan
•      Mineralocorticoid receptor antagonists: finerenone
•      Neuropsychiatric agents: cariprazine
•      Opioid antagonists: naloxegol
•      PDE5 inhibitor: avanafil, sildenafil, tadalafil, vardenafil
•      Sedative/hypnotics: clorazepate, diazepam, estazolam, flurazepam, oral midazolam and triazolam
•      Vasopressin receptor antagonists: tolvaptan

Medicinal products that are potent CYP3A inducers where significantly reduced nirmatrelvir/ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance.

•    Antibiotics: rifampicin, rifapentine
•    Anticancer drugs: apalutamide, enzalutamide
•    Anticonvulsants: carbamazepine, phenobarbital, phenytoin, primidone •    Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor •    Herbal products: St. John’s wort (Hypericum perforatum)

Paxlovid cannot be started immediately after discontinuation of CYP3A4 inducers due to the delayed offset of the recently discontinued CYP3A4 inducer (see section 4.5).

A multi-disciplinary approach (e.g., involving physicians and specialists in clinical pharmacology) should be considered to determine the adequate timing for Paxlovid initiation taking into account the delayed offset of the recently discontinued CYP3A inducer and the need to initiate Paxlovid within 5 days of symptom onset.