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Acomplia (rimonabant) - licence suspension
Use of this medicine has been suspended by the European medicines agency (EMEA).
The following advice has been issued by the EMEA to patients and healthcare professionals:
- Patients currently on Acomplia (rimonabant) should consult their doctor or pharmacist to discuss their treatment.
- There is no need for patients to stop treatment immediately, but patients who wish to stop can do so at any time
- Patients currently in clinical trials of Acomplia (rimonabant) should contact the investigator (the doctor who is treating you), who will be able to provide more information.
- Prescribers should not issue any prescriptions for Acomplia (rimonabant) and should review patients currently on this treatment
As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia.
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- Water for Injections
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- NovoRapid 100 U/ml in a vial, NovoRapid Penfill 100 U/ml, NovoRapid FlexPen 100 U/ml, NovoRapid FlexTouch 100 U/ml
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Other
Rimonabant
20 mg Film-coated tablet Biconvex, teardrop-shaped, white tablets debossed with “20” on one side.
Each tablet contains 20 mg rimonabant. Excipients: The tablets contain approx. 115 mg lactose.
Acomplia (rimonabant) - licence suspension
Use of this medicine has been suspended by the European medicines agency (EMEA).
The following advice has been issued by the EMEA to patients and healthcare professionals:
- Patients currently on Acomplia (rimonabant) should consult their doctor or pharmacist to discuss their treatment.
- There is no need for patients to stop treatment immediately, but patients who wish to stop can do so at any time
- Patients currently in clinical trials of Acomplia (rimonabant) should contact the investigator (the doctor who is treating you), who will be able to provide more information.
- Prescribers should not issue any prescriptions for Acomplia (rimonabant) and should review patients currently on this treatment
As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia.
Paediatrics: ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Elderly: No dosage adjustment is required in elderly. ACOMPLIA should be used with caution in patients over 75 years of age (See Special Precautions).
Hypersensitivity to the active substance or to any of the excipients Lactation.
Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment. The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended. There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment. Rimonabant should not be used in patients with severe renal impairment (See Adult Dosage). The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently been established. Rimonabant should be used with caution in this population.
Rimonabant has not been studied in patients being treated for epilepsy. In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo. Rimonabant, however, should be used with caution in these patients. The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians. This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure.
Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(See Interactions). Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine. Patients should be instructed not to increase their dose of ACOMPLIA. Obesity is a condition that can be associated with depression or other psychiatric conditions. Depressive disorders have been reported in patients receiving rimonabant 20 mg (See Adverse Reactions). Therapy with rimonabant should not be initiated in patients with uncontrolled serious psychiatric illness such as a major depression.
Appropriate treatment of this condition should be initiated first and therapy with rimonabant considered once this psychiatric condition is controlled. As there is limited data in patients with antidepressant medication in combination with rimonabant, use of rimonabant is not recommended in these patients. Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago were excluded in the studies for rimonabant.
Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro. Co-administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant.
Co-administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant. Potential for other medicinal products to affect rimonabant: Concomitant administration of ketoconazole (apotent CYP3A4 inhibitor) increased rimonabant AUC by 104% (95% prediction interval: 40% - 197%).
A similar increase in exposure is expected with other potent CYP3A4 inhibitors. Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone). Although concomitant administration of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of efficacy. Co-administration of orlistat, ethanol or lorazepam had no significant effect on the plasma levels of rimonabant.
Potential for rimonabant to affect other medicinal products: The in vivo inhibitory effect on CYP2C8 has not been studied. However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8. The potential for inhibition of CYP2C8 in vivo appears to be low.Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro. This was confirmed clinically with specific probe studies using midazolam (CYP 3A4 substrate) and warfarin (CYP 2C9 substrate) and digoxin (a P-gp substrate). The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant.
Pregnancy and lactation:
There are no adequate or well-controlled studies in pregnant women. Animal data are inconclusive but suggest possible deleterious effects on embryonal/foetal development. The potential risk for humans is unknown. Use in pregnancy is, therefore, not recommended. Patients should notify their physician if they become pregnant during treatment with ACOMPLIA.
Rimonabant has been detected in the milk of lactating ratsand rimonabant may inhibit the suckling reflex. It is not known if rimonabant is excreted in human milk. ACOMPLIA is contraindicated during breast-feeding (See Contraindications).
During the studies, the most common side effects with ACOMPLIA (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract. For the full list of all side effects reported with ACOMPLIA, see the Package Leaflet.
ACOMPLIA should not be used in patients who may be hypersensitive (allergic) to rimonabant or any of the other ingredients, or in women who are breast feeding. It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of depression, including thoughts about suicide in a small minority of patients.
Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment. Caution should be used when taking ACOMPLIA with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Sanofi-Aventis
(POM)
19 August 2010
