Bulevirtide interacts in the following cases:
In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥0.5 µM, which is only reached in vivo after administration of high bulevirtide doses (10 mg subcutaneous). The clinical relevance of these findings is unknown. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates (e.g. atorvastatin, bosentan, docetaxel, fexofenadine, glecaprevir, glyburide (glibenclamide), grazoprevir, nateglinide, paclitaxel, paritaprevir, pitavastatin, pravastatin, repaglinide, rosuvastatin, simeprevir, simvastatin, olmesartan, telmisartan, valsartan, voxilaprevir) are co-administered. When possible, co-administration of these substrates should be avoided.
As a precautionary measure, close clinical monitoring is warranted when NTCP substrates (e.g. estrone3-sulfate, fluvastatin, atorvastatin, pitavastatin, pravastatin, rosuvastatin, and thyroid hormones) are coadministered with bulevirtide. When possible, co-administration of these substrates should be avoided.
In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodiumtaurocholate co-transporting polypeptide (NTCP). The co-administration of ciclosporin A is not recommended.
In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodiumtaurocholate co-transporting polypeptide (NTCP). The co-administration of ezetimibe is not recommended.
In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodiumtaurocholate co-transporting polypeptide (NTCP). The co-administration of irbesartan is not recommended.
In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodiumtaurocholate co-transporting polypeptide (NTCP). The co-administration of ritonavir is not recommended.
In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodiumtaurocholate co-transporting polypeptide (NTCP). The co-administration of sulfasalazin is not recommended.
The pharmacokinetics, safety and efficacy of bulevirtide in patients with decompensated cirrhosis has not been established. The use in patients with decompensated liver disease is not recommended.
There are no or limited amount of data from the use of bulevirtide in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
As a precautious measure, it is preferable to avoid the use of bulevirtide during pregnancy and in women of child-bearing age who do not use contraception.
It is unknown whether bulevirtide is excreted in human breast milk. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue/abstain from treatment with bulevirtide, taking into account the benefit of breastfeeding for the child with regard to the benefit of treatment for the mother.
No human data on the effect of bulevirtide on fertility are available. In animal studies, no effects of bulevirtide on male or female mating and fertility were noted.
The product has minor influence on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with bulevirtide.
The most frequently reported adverse reactions were asymptomatic, dose dependent and reversible (after discontinuation of treatment) increase in bile salts (very common) and injection site reactions (common).
The most frequently reported serious adverse reaction was an exacerbation of hepatitis after discontinuation of bulevirtide, possibly related to virologic rebound after discontinuation of treatment.
Common and very common adverse reactions are listed below by system organ class and absolute frequency. Frequencies are defined as follows: very common (≥1/10), common (≥1/100, <1/10).
| Med DRA System Organ Class | Adverse reactions | |
|---|---|---|
| Very common (≥1/10) | Common (≥1/100 to <1/10) | |
| Blood and lymphatic system disorders | Anaemia Eosinophilia Leukopenia Lymphopenia Neutropenia Reticulocytopenia Thrombocytopenia | |
| Nervous system disorders | Dizziness Headache Somnolence | |
| Cardiac disorders | Tachycardia | |
| Gastrointestinal disorders | Abdominal distention Nausea | |
| Skin and subcutaneous tissue disorders | Erythema Hyperhidrosis Pruritus Rash | |
| Musculoskeletal and connective tissue disorders | Arthralgia Muscle spasms | |
| Renal and urinary disorders | Haematuria | |
| General disorders and administration site conditions | Fatigue Influenza like illness Injection site erythema Injection site haematoma Injection site pruritus Injection site dermatitis Local reaction | |
| Investigations | Total bile salt increased | ALT increased Amylase increased AST increased Blood bilirubin increased Blood creatinine increased GGT increased Haemoglobin decreased INR increased Lipase increased Neutrophil count decreased |
Most ALT elevations were reported after treatment cessation and may be related to hepatitis exacerbation after withdrawal of antiviral treatment.
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