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Follitrope

Follitrope

follitropin alfa

Manufacturer:

LG Chem

Distributor:

Faberco

Marketer:

Faberco
Concise Prescribing Info Full Prescribing Info Contents Description Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing
Concise Prescribing Info
Contents
Follitropin alfa
Indications/Uses
Female infertility in the following clinical situations: Controlled ovarian hyperstimulation to induce development of multiple follicles in medically assisted reproduction program [eg, in vitro fertilization (IVF), gamete & zygote intra-fallopian transfer, intracytoplasmic sperm inj]; anovulation in clomiphene-resistant anovulatory infertility women [WHO Group II, including polycystic ovarian disease (PCOD)].
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Dosage/Direction for Use
SC/IM Ovarian stimulation for multiple follicular development prior to IVF or other assisted reproductive technology 150-300 IU daily, commencing on days 2-5 of the cycle. Continue treatment until adequate follicular development has been achieved, w/ dose adjusted according to patient's response, to usually max 450 IU daily. Administer single inj of HCG 48 hr after last follitropin alfa inj. Anovulation (including PCOD) 75-150 IU FSH daily, increased by 75 IU at 7- or preferably 14-day intervals if necessary. Max daily dose: 225 IU FSH. Commence treatment w/in the 1st 7 days of menstrual cycle in menstruating patient. When optimal response is obtained, administer single inj of HCG 24-48 hr after the last follitropin alfa inj.
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Overdosage
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Contraindications
Hypersensitivity. Tumors of the ovary, breast, uterus, hypothalamus or pituitary gland. Undiagnosed vag bleeding. Primary ovarian failure. Ovarian cysts or enlarged ovaries, not related to PCOD. Malformations of sexual organs incompatible w/ pregnancy. Fibroid tumors of uterus incompatible w/ pregnancy. Presence of uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal or pituitary disorders). Pregnancy & lactation.
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Warnings
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Special Precautions
Possibility of anaphylaxis response. Incidence of ectopic pregnancies might be increased. Perform ultrasonographic assessment of follicular development, & determination of oestradiol levels prior to treatment & at regular intervals during treatment. Discontinue FSH administration & w/hold HCG if unwanted ovarian hyperstimulation occurs. Increased risk of ovarian hyperstimulation syndrome (OHSS) & multiple pregnancy in anovulation by high serum oestradiol conc & number of matured follicles; monitoring is required. Higher rates of pregnancy loss in women undergoing assisted reproduction techniques treated w/ FSH.
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Use In Pregnancy & Lactation
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Adverse Reactions
Headache, enlarged abdomen, displeasure; fatigue, dizziness, nausea, side abdomen pain, ovarian hyperstimulation & fever. Inj site reaction eg, bruising, pain, swelling & itching. Ectopic pregnancy & multiple pregnancies.
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Drug Interactions
Follicular response may be enhanced w/ clomiphene citrate. Higher dose of follitropin alfa may be necessary to achieve adequate follicular response after pituitary desensitization induced by gonadotropin release hormone analogue.
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Caution For Usage
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Storage
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Description
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MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Regulatory Classification
Rx
Presentation/Packing
Form
Follitrope soln for inj 150 IU/0.3 mL
Packing/Price
1's
Form
Follitrope soln for inj 225 IU/0.45 mL
Packing/Price
1's
Form
Follitrope soln for inj 300 IU/0.6 mL
Packing/Price
1's
Form
Follitrope soln for inj 75 IU/0.15 mL
Packing/Price
1's