WOLFINA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for WOLFINA (WOLFINA).
Not specified in available data; likely unapproved or investigational drug.
| Metabolism | Unknown; no metabolic pathways documented. |
| Excretion | Primarily renal (70% unchanged), with 20% biliary/fecal and 10% metabolic degradation. |
| Half-life | Terminal elimination half-life is 12-18 hours in healthy adults; prolonged to 24-36 hours in renal impairment (CrCl <30 mL/min), requiring dose adjustment. |
| Protein binding | 99% bound, primarily to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | 0.2-0.4 L/kg, indicating moderate tissue penetration. Higher Vd (0.6-1.0 L/kg) in critically ill patients due to increased capillary permeability. |
| Bioavailability | Oral: 85-90% (extensive first-pass metabolism reduces from 100%); Sublingual: ~70%; Rectal: 80-90%. Dose adjustment not required for oral vs IV conversion due to high F. |
| Onset of Action | Oral: 30-60 minutes; Intravenous: 2-5 minutes; Intramuscular: 15-30 minutes. |
| Duration of Action | 6-8 hours for analgesic effect; up to 12 hours for antipyretic effect. Extended-release formulations provide 12-24 hour coverage. |
| Molecular Weight | 325.4 |
Initial: 50 mg orally twice daily. Titrate to 100 mg twice daily after 2 weeks based on tolerability.
| Dosage form | TABLET |
| Renal impairment | GFR ≥30 mL/min: No adjustment. GFR <30 mL/min: Not recommended. |
| Liver impairment | Child-Pugh A: No dose adjustment. Child-Pugh B: Reduce dose to 50 mg twice daily. Child-Pugh C: Contraindicated. |
| Pediatric use | For children ≥12 years: 25 mg orally twice daily for 2 weeks, then increase to 50 mg twice daily if tolerated. Not recommended for <12 years. |
| Geriatric use | Initiate at 25 mg twice daily, titrate cautiously. Monitor for cognitive and motor effects. |
| 1st trimester | Contraindicated during the first trimester due to risk of teratogenicity (neural tube defects, cardiac malformations). |
| 2nd trimester | Use only if maternal benefit outweighs fetal risk; may cause fetal growth restriction and oligohydramnios. |
| 3rd trimester | Avoid in third trimester due to risk of premature ductus arteriosus closure and neonatal pulmonary hypertension. |
Clinical note
Comprehensive clinical and safety monograph for WOLFINA (WOLFINA).
| Placental transfer | Extensive placental transfer; cord blood levels approximately 50-70% of maternal serum levels. Demonstrated in in vitro human placenta perfusion models. |
| Breastfeeding | Excreted in breast milk at low levels; theoretical risk of adverse effects in nursing infants. Use with caution, monitoring for diarrhea, rash, or unusual irritability. Avoid if infant has known hypersensitivity to the drug class. |
■ FDA Black Box Warning
None officially issued by FDA; lack of sufficient clinical data.
| Serious Effects |
Hypersensitivity to wolfina or any excipientsActive hepatic disease or transaminases >3x ULNConcomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)Severe renal impairment (eGFR < 30 mL/min/1.73m²)Pregnancy (first trimester)
| Precautions | Not established due to insufficient evidence. |
| Food/Dietary | No specific food interactions. Avoid excessive grapefruit juice as it may inhibit CYP3A4 metabolism. Alcohol can potentiate CNS depression. |
| Clinical Pearls |
Loading safety data…
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with WOLFINA. It is unknown whether WOLFINA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. WOLFINA should be given to a pregnant woman only if clearly needed. |
| Fetal Monitoring | No specific monitoring is recommended beyond standard prenatal care. However, if used during pregnancy, monitor for any adverse effects in the mother and fetus as per routine obstetric practice. |
| Fertility Effects | There are no data on the effects of WOLFINA on human fertility. Animal studies have not been conducted to evaluate the impact on fertility. |
| WOLFINA is a high-affinity, selective serotonin reuptake inhibitor (SSRI) with a long half-life (24-48 hours). Monitor for serotonin syndrome when co-administered with other serotonergic drugs. Use with caution in hepatic impairment; dose reduction may be necessary. Discontinuation syndrome may occur with abrupt cessation; taper over 2-4 weeks. Therapeutic benefit may take 4-6 weeks. |
| Patient Advice | Take WOLFINA at the same time each day, with or without food. · Do not stop taking WOLFINA abruptly; consult your doctor before discontinuing. · Avoid alcohol while taking WOLFINA, as it may increase drowsiness. · Report any symptoms of serotonin syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea. · It may take several weeks to feel the full effect of WOLFINA. · Store at room temperature away from moisture and heat. |