Certican

Certican

everolimus

Manufacturer:

Novartis

Distributor:

DKSH
Concise Prescribing Info
Contents
Everolimus
Indications/Uses
In combination w/ ciclosporin for microemulsion & corticosteroids for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In combination w/ tacrolimus & corticosteroids for the prophylaxis of organ rejection in adult patients receiving hepatic transplant.
Dosage/Direction for Use
Adult General kidney & heart transplant population Initially 0.75 mg bd administered as soon as possible after transplantation. Hepatic transplant 1 mg bd w/ initial dose starting approx 4 wk after transplantation.
Administration
May be taken with or without food: Take consistently either always w/ or always w/o meals. Swallow whole, do not crush. Avoid grapefruit products.
Contraindications
Hypersensitivity to everolimus or sirolimus.
Special Precautions
Discontinue use if interstitial lung disease occurs. Increased risk of developing lymphomas & other malignancies, kidney arterial & venous thrombosis, calcineurin inhibitor-induced hemolytic uremic syndrome/thrombotic thrombocytopenic purpura/thrombotic microangiopathy & new onset DM. Immune system oversuppression w/ increased susceptibility to infections. Angioedema; proteinuria. Impaired wound healing. Not recommended in concomitant use w/ strong CYP3A4 inhibitors & inducers. Concomitant use w/ thymoglobulin induction. Regular monitoring of blood drug levels, proteinuria, renal function. Closely monitor blood glucose conc. Galactose intolerance, severe lactase deficiency, glucose-galactose malabsorption. Women & men of childbearing potential should use effective contraception during & up to 8 wk after therapy. Risk for male infertility in prolonged use. Not to be used during pregnancy & lactation.
Adverse Reactions
Viral, bacterial & fungal infections, upper & lower resp tract infection, UTI, anaemia/erythropenia, leukopenia, thrombocytopenia, hyperlipidaemia, new onset DM, hypokalaemia, insomnia, anxiety, headache, venous thromboembolic events, HTN, cough, dyspnoea, diarrhoea, nausea, vomiting, abdominal pain, pericardial & pleural effusion, peripheral oedema, healing impairment, pain, pyrexia. Malignant & unspecified tumours, skin neoplasms, wound infection, sepsis, pancytopenia, thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome, tachycardia, epistaxis, lymphocele, renal graft thrombosis, stomatitis/mouth ulceration, oropharyngeal pain, myalgia, angioedema, acne, arthralgia, pancreatitis, proteinuria, erectile dysfunction, renal tubular necrosis, incisional hernia, abnormal hepatic enzyme.
Drug Interactions
CYP3A4 & CYP2D6 substrates w/ narrow therapeutic index; rifampicin, rifabutin or ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin or ritonavir; CYP3A4 inducers eg, St. John's wort, anticonvulsants (eg, carbamazepine), phenobarb, phenytoin, anti-HIV drugs (eg, efavirenz, nevirapine), erythromycin, verapamil, P-gp inhibitors, moderate CYP3A4 inhibitors (eg, fluconazole, nicardipine, diltiazem, nelfinavir, indinavir, amprenavir, octreotide, midazolam). Avoid grapefruit & grapefruit juice; live vaccines.
MIMS Class
Immunosuppressants
ATC Classification
L04AA18 - everolimus ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
Presentation/Packing
Form
Certican tab 0.25 mg
Packing/Price
6 × 10's
Form
Certican tab 0.75 mg
Packing/Price
6 × 10's
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