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  • REKAMBYS
    / Janssen


    Active Ingredient
    Rilpivirine 600 mg, 900 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Prolonged-release suspension for injection

    1 x 600 mg

    partial basket chart

    Prolonged-release suspension for injection

    1 x 900 mg

    partial basket chart

    Related information


    Dosage

    Therapy should be prescribed by a physician experienced in the management of HIV infection. Each injection should be administered by a healthcare professional.
    Rilpivirine tablets as an oral lead-in prior to the initiation of REKAMBYS injections to assess tolerability, or proceed directly to REKAMBYS therapy.
    Every 1 month dosing
    Initiation injection
    On the final day of current antiretroviral therapy or oral lead-in, the recommended initiation injection dose of rilpivirine in adults is a single 900 mg intramuscular injection.
    Continuation injection
    After the initiation injection, the recommended continuation injection dose of rilpivirine in adults is a single 600 mg monthly intramuscular injection. Patients may be given injections up to 7 days before or after the date of the monthly injection schedule.
    Every 2 months dosing
    Initiation Injections –1 month apart
    On the final day of current antiretroviral therapy or oral lead-in, the recommended initial rilpivirine injection dose in adults is a single 900 mg intramuscular injection.
    One month later, a second 900 mg intramuscular injection should be administered. Patients may be given the second 900 mg injection up to 7 days before or after the scheduled dosing date.
    Continuation Injections – 2 months apart
    After the initiation injections, the recommended rilpivirine continuation injection dose in adults is a single 900 mg intramuscular injection administered every 2 months. Patients may be given injections up to 7 days before or after the date of the every 2 months injection schedule.
    See prescribing information for full details.


    Indications

    Human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class. In combination with cabotegravir injection.


    Contra-Indications

    * Hypersensitivity to the active substance or to any of the excipients.
    * Must not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction), which may result in loss of therapeutic effect.
    – Anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin
    – Antimycobacterials rifabutin, rifampicin, rifapentine
    – Systemic glucocorticoid dexamethasone, except as a single dose treatment
    – St John’s wort (Hypericum perforatum)


    Special Precautions

    Risk of resistance following treatment discontinuation
    To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than one month after the last every 1 month injection or two months after the last every 2 months injection.
    If virologic failure is suspected, an alternative regimen should be adopted as soon as possible.
    Long-acting properties of rilpivirine injection
    Residual concentrations of rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 4 years in some patients) and should be considered upon discontinuation.
    Post-injection reactions
    Accidental intravenous administration may result in AEs due to temporarily high plasma concentrations. In clinical studies, serious post-injection reactions were reported within minutes after the injection of rilpivirine. These events included symptoms such as dyspnoea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events were very rare and began to resolve within minutes after the injection. Some of the patients received symptomatic treatment, at the discretion of the treating physician.
    Carefully follow the Instructions for Use when preparing and administering. Observe patients briefly (approximately 10 minutes) after the injection. If a patient experiences a post-injection reaction, monitor and treat as clinically indicated.
    Cardiovascular
    Should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes. At supra-therapeutic doses (75 and 300 mg once daily), oral rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG). Oral rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. Plasma rilpivirine concentrations after injections are comparable to those during such oral rilpivirine therapy.
    HBV/HCV co-infection
    Patients with hepatitis B co-infection were excluded from studies. It is not recommended to initiate rilpivirine in patients with hepatitis B co-infection. In patients co-infected with hepatitis B receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis B co-infected. Physicians should refer to current treatment guidelines for the management of HIV infection in patients co-infected with hepatitis B virus.
    Limited data is available in patients with hepatitis C co-infection. In patients co-infected with hepatitis C receiving oral rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving oral rilpivirine who were not hepatitis C co-infected. The pharmacokinetic exposure of oral and injectable rilpivirine in co-infected patients was comparable to that in patients without hepatitis C co-infection. Monitoring of liver function is recommended in patients with hepatitis C co-infection.
    Interactions with other medicinal products
    Should not be administered with other antiretroviral medicinal products, except for cabotegravir injection for the treatment of HIV-1 infection.
    Immune reactivation syndrome
    In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution, however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
    Opportunistic infections
    Opportunistic infections and other complications of HIV infection may still develop. Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases.
    See prescribing information for full details.


    Side Effects

    Very common: increased total cholesterol (fasted), increased LDL cholesterol (fasted), headache, increased pancreatic amylase, injection site reactions (pain and discomfort, nodule, induration), pyrexia,
    Common: decreased white blood cell count, decreased haemoglobin, decreased platelet count, decreased appetite, increased triglycerides (fasted), depression, anxiety, abnormal dreams, insomnia, sleep disorder, depressed mood, dizziness, nausea, vomiting, abdominal pain, flatulence, diarrhoea, abdominal discomfort, dry mouth, increased lipase, rash, myalgia, injection site reactions (swelling, erythema, pruritus, bruising, warmth, haematoma), fatigue, asthenia, malaise, weight increased.
    See prescribing information for full details.


    Drug interactions

    * Should not be administered with other antiretroviral medicinal products for the treatment of HIV-1.
    * When using oral rilpivirine, proton pump inhibitors are contraindicated.
    Medicinal products that affect rilpivirine exposure
    Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A. Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine.
    Co-administration of rilpivirine and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine, which could reduce the therapeutic effect of rilpivirine.
    Co-administration of rilpivirine and medicinal products that inhibit CYP3A has been observed to increase the plasma concentrations of rilpivirine.
    Medicinal products that are affected by the use of rilpivirine
    Rilpivirine inhibits P-glycoprotein in vitro (IC50 is 9.2 μM). In a clinical study, oral rilpivirine (25 mg once daily) did not significantly affect the pharmacokinetics of digoxin.
    QT prolonging medicinal products
    Should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: A moderate amount of data with oral rilpivirine in pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or foetal/neonatal toxicity of rilpivirine.
    Lower exposures of oral rilpivirine during the second and third trimesters and postpartum, therefore viral load should be monitored closely if REKAMBYS is used during pregnancy.
    An alternative oral regimen should be considered in line with current treatment guidelines. After discontinuation of this medical product, rilpivirine may remain in systemic circulation for up to 4 years in some patients
    Lactation: In order to avoid transmission of HIV to the infant it is recommended that women living with HIV do not breast-feed.


    Overdose

    There is currently limited experience with REKAMBYS overdose. If overdose occurs, the patient should be treated supportively and as clinically indicated, with monitoring of vital signs and ECG (QT interval), as necessary. Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.


    Important notes

    Fatigue, dizziness and somnolence could occur when treated with this medical product


    Manufacturer
    Cilag AG
    Licence holder
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