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Name /bks_53161_deglins_md_disk/follitropinalfa 03/03/2014 09:05AM Plate # 0-Composite pg 1 # 1 1 Use Cautiously in: None known. follitropin alfa (foll-i-tro-pin) Adverse Reactions/Side Effects CNS: dizziness, headache. CV: THROMBOEMBOLIC EVENTS. EENT: pharyngitis, rhinitis. GI: constipation, diarrhea, dyspepsia, flatulence. GU: OVARIAN HYPERSTIMULA- Gonal-F, Gonal-F RFF Classification Therapeutic: hormones (ovulation stimulant) Pregnancy Category X TION SYNDROME, abdominal/pelvic pain, dysmenorrhea, irregular bleeding, ovarian enlargement, ovarian torsion. Derm: acne. Endo: breast pain. Resp: cough. Local: injection site reactions. Misc: ANAPHYLAXIS, flu-like symptoms, multiple births. Indications Induction of ovulation in anovulatory patients whose infertility is not due to primary ovarian failure (Gonal-F and Gonal-F RFF). Stimulation of multiple oocytes in ovulatory patients undergoing assisted reproduction technology (ART) (Gonal-F and Gonal-F RFF). Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism whose infertility is not due to primary testicular failure (Gonal-F only). Interactions Drug-Drug: Unknown. Route/Dosage Female infertility Subcut (Adults): 75 IU/day for 14 days, then increased by 37.5 IU at weekly intervals as needed by assessment (up to 300 IU/day); followed by hCG. Action Assisted Reproduction Technologies Stimulates follicle recruitment, growth and maturation. Induces spermatogenesis. Therapeutic Effects: Ovulation. Improved production/harvest of oocytes in patients undergoing ART. Spermatogenesis. Subcut (Adults): 150 IU/day starting on day 2 or 3 of cycle until follicles develop sufficiently; if needed may be increased by 75– 150 IU/day every 3– 5 days (not to exceed 10 days or 450 IU/day); followed by hCG. Pharmacokinetics Absorption: Well absorbed following subcut administration. Distribution: Unknown. Metabolism and Excretion: Unknown. Half-life: 24 hr. Male Patients with Hypogonadotropic Hypogonadism (Gonal-F only) Subcut (Adults): After normal serum testosterone levels are achieved with hCG, Gonal– F can be initiated at 150 IU 3 times weekly (must be given with hCG). If azoospermia persists, dose can be increased up to 300 IU 3 times weekly; may be given for up to 18 mo. TIME/ACTION PROFILE ROUTE ONSET PEAK DURATION Subcut unknown unknown unknown Contraindications/Precautions Contraindicated in: Hypersensitivity; Primary ovarian or testicular failure; OB: Pregnancy; Uncontrolled thyroid, adrenal, or pituitary dysfunction; Abnormal uterine bleeding; Intracranial or hormone-dependent tumors; Ovarian cyst/enlargement not due to polycystic ovarian syndrome. ⫽ Canadian drug name. ⫽ Genetic Implication. NURSING IMPLICATIONS Assessment ● Monitor follicular maturation during therapy via ovarian ultrasound and serum estradiol levels. ● Assess patient for ovarian enlargement (abdominal distention, abdominal pain). Usually regresses without treatment within 2– 3 wks. ● For men, monitor serum testosterone levels and sperm counts. Prior to concomi- tant therapy with follitropin alfa and hCG, pretreatment with hCG alone is required CAPITALS indicate life-threatening, underlines indicate most frequent. Strikethrough ⫽ Discontinued. PDF Page #1 Name /bks_53161_deglins_md_disk/follitropinalfa 03/03/2014 09:05AM Plate # 0-Composite pg 2 # 2 ● Encourage couple to have intercourse daily, beginning on the day prior to admin- 2 to achieve normal serum testosterone levels. Pretreatment with hCG may require 3– 6 mo. Serum testosterone levels should be normalized prior to initiation of therapy. ● Toxicity and Overdose: Assess patient for signs of ovarian hyperstimulation syndrome (severe ovarian enlargement, abdominal pain and distention, nausea, vomiting, weight gain, diarrhea, dyspnea, oliguria). May be accompanied by ascites, pleural effusion, hypovolemia, electrolyte imbalance, hemoperitoneum, thromboembolic events. istration of hCG until ovulation becomes apparent based on indices to determine progestational activity. Care should be taken to ensure insemination. Evaluation/Desired Outcomes ● Successful pregnancy. ● Increased sperm count. Why was this drug prescribed for your patient? Potential Nursing Diagnoses Deficient knowledge, related to medication regimen (Patient/Family Teaching) Implementation ● Subcut: Administer via subcut injection only. Vials: Dissolve the contents of each vial with sterile or bacteriostatic water for injection provided in accompanying pre-filled syringe. For single-dose vial, use immediately after reconstitution and discard unused solution. Multi-dose vials may be stored in refrigerator or at room temperature for up to 28 days. Dose from multi-dose vials should be administered with calibrated syringes provided by manufacturer. Protect all vials from light. Pre-filled pens: Pens should be at room temperature before using. Remove protective pen cap. Remove peel tab from outer needle cap on single-use disposable needle (provided in carton). Press threaded tip of pen into open end of outer needle cap and twist it clockwise until securely fixed. Remover outer needle cap (but don’t throw away). Do not remove the inner needle cap at this time. Select prescribed dose by turning dosage dial to proper dose mark. Pull out injection button on pen as far as it will go. Remover inner needle cap on pen. Insert needle into abdominal skin at 90 degree angle and push injection button. Allow needle to remain in skin for at least 5 sec to ensure that full dose is injected. Remove needle. Replace outer needle cap onto needle. Remove needle by unscrewing pen counter-clockwise and dispose of in safety container. Replace protective pen cap. Unused pens may be stored in refrigerator until expiration date or at room temperature for up to 1 mo or until expiration date, whichever occurs first. Used pens may be stored in refrigerator or at room temperature for up to 28 days. Pens should be protected from light. Patient/Family Teaching ● Prior to initiation of therapy discuss with patient the duration of therapy, required monitoring, potential adverse reactions, and risk of multiple births. 䉷 2015 F.A. Davis Company PDF Page #2