Implanon NXT

Implanon NXT

etonogestrel

Manufacturer:

Organon

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Etonogestrel
Dosage/Direction for Use
Subdermal insertion A single implant can be left in place for 3 yr. Remove the implant no later than 3 yr after the date of insertion. No preceding hormonal contraceptive use in the past mth Insert between day 1 & 5 of the menstrual cycle, even if the woman is still bleeding. Changing from a combined hormonal contraceptive method [combined oral contraceptive (COC), vag ring or transdermal patch] Insert preferably on the day after the last active tab of the previous COC, but at the latest on the day following the usual tab-free or placebo tab interval of the previous COC. In case a vag ring or transdermal patch has been used, insert implant preferably on the day of removal, but at the latest when the next application would have been due. Changing from a progestagen-only contraceptive method [eg, progestagen-only pill, injectable, implant or intrauterine system (IUS)] Injectable contraceptives: Insert when the next inj is due. Progestagen-only pill: Insert w/in 24 hr after the last tab. Implant/IUS: Insert on the same day the previous implant/IUS is removed. Following 1st trimester abortion or miscarriage Insert w/in 5 days following 1st trimester abortion or miscarriage. Following 2nd trimester abortion or miscarriage Insert between day 21-28 following 2nd trimester abortion or miscarriage. Postpartum Breastfeeding: Insert after the 4th postpartum wk. Use a barrier method until 7 days after insertion. Non-breastfeeding: Insert between 21-28 days postpartum. If implant is inserted later than 28 days postpartum, use barrier method until 7 days after insertion.
Contraindications
Hypersensitivity. Active venous thromboembolic disorder. Known or suspected sex steroid sensitive malignancies. Undiagnosed vag bleeding. Presence or history of liver tumours (benign or malignant), severe hepatic disease (as long as liver function values have not returned to normal). Known or suspected pregnancy.
Special Precautions
Exclude pregnancy prior to insertion. Risk of breast cancer. Refer patient to a specialist for exam & advice if acute or chronic liver function disturbances occur. History of thromboembolic disorders. Possible serious arterial & venous thromboembolic events including pulmonary emboli, DVT, MI & strokes. Remove implant in case of long-term immobilization due to surgery or illness; in the event of a thrombosis; if sustained HTN develops during use or if significant increase in BP does not adequately respond to antihypertensive therapy. Carefully observe diabetic women & those being treated for hyperlipidemia. Possible chloasma especially in women w/ history of chloasma gravidarum; avoid exposure to sun or UV radiation. Consider earlier implant replacement in heavier women. Expulsion may occur if implant is not inserted accordingly or as a consequence of local inflammation. Possible migration of implant w/in the arm from the insertion site; implants located w/in the vessels of the arm & pulmonary artery. Follicular development may occur in low-doses. Ectopic pregnancy. Jaundice &/or pruritus related to cholestasis, gallstone formation, porphyria, SLE, hemolytic uraemic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis-related hearing loss & hereditary angioedema. Take a complete medical history prior to initiation or reinstitution; measure BP & perform physical exam. Advise women that Implanon NXT does not protect against HIV (AIDS) & other STD. Concomitant use w/ medications that decrease plasma conc of etonogestrel. Changes in the menstrual bleeding pattern. Broken or bent implants; when an implant is removed, it is important to remove it in its entirety. May affect laboratory parameters including biochemical parameters of liver, thyroid, adrenal & renal function; serum levels of (carrier) proteins eg, corticosteroid binding globulin & lipid/lipoprotein fractions; parameters of carbohydrate metabolism, coagulation & fibrinolysis. Advise women to use a barrier method until 7 days after insertion if deviating from the recommended timing of insertion. Lactation (insert after the 4th post-partum wk).
Adverse Reactions
Vag infection; headache; acne; breast tenderness & pain, irregular menstruation; increased wt. Increased appetite; affect lability, depressed mood, nervousness, decreased libido; dizziness; hot flush; abdominal pain, nausea, flatulence; alopecia; dysmenorrhea, ovarian cyst; implant site pain & reaction, fatigue, flu-like illness, pain; decreased wt.
Drug Interactions
Increased clearance, reduced plasma conc of sex hormones & may decrease effectiveness w/ CYP450 enzyme inducers [eg, phenytoin, phenobarb, primidone, bosentan, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, HIV PIs (eg, ritonavir), NNRTIs (eg, efavirenz), St. John's wort]. Increased or decreased plasma conc w/ HIV PIs (eg, nelfinavir), NNRTIs (eg, nevirapine) &/or combinations w/ HCV medicinal products (eg, boceprevir, telaprevir). May increase serum conc w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. May increase plasma & tissue conc of ciclosporin. May decrease plasma & tissue conc of lamotrigine.
MIMS Class
Depot Contraceptives
ATC Classification
G03AC08 - etonogestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
Presentation/Packing
Form
Implanon NXT implant 68 mg
Packing/Price
1's
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