Follitropin delta parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Solution for injection containing follitropin delta.
These products have been produced by recombinant technology using a human cell line (PER.C6).
Controlled superovulation in medically assisted conception programmes
For controlled ovarian stimulation, to enable the development of multiple follicles in women undergoing assisted reproductive technologies e.g. in vitro fertilisation or intracytoplasmic sperm injection.
The dose must be individualised for each patient to achieve a adequate ovarian response whilst maintaining a favourable safety/efficacy profile.
For the first treatment cycle, dose should be determined according to body weight and serum anti-Mullerian hormone (AMH). A recent (within 12 months) measurement of AMH should be obtained, using ELECSYS AMH Plus immunoassay. Results from other assays may not be suitable for determining dose. The individual daily dose is to be maintained throughout the stimulation period.
In women with AMH less than 15pmol/litre: 12micrograms daily.
In women with AMH of 15 to 16pmol/litre: 0.19micrograms/kg daily.
In women with AMH of 17pmol/litre: 0.18micrograms/kg daily.
In women with AMH of 18pmol/litre: 0.17micrograms/kg daily.
In women with AMH of 19 to 20pmol/litre: 0.16micrograms/kg daily.
In women with AMH of 21 to 22pmol/litre: 0.15micrograms/kg daily.
In women with AMH of 23 to 24pmol/litre: 0.14micrograms/kg daily.
In women with AMH of 25 to 27pmol/litre: 0.13micrograms/kg daily.
In women with AMH of 28 to 32pmol/litre: 0.12micrograms/kg daily.
In women with AMH of 33 to 39pmol/litre: 0.11micrograms/kg daily.
In women with AMH greater than or equal to 40pmol/litre: 0.10micrograms/kg daily.
If the AMH is expressed in ng/ml, it should be converted to pmol/litre by multiplying with 7.14 (ng/ml x 7.14 = pmol/litre)
The daily dose should be rounded to the nearest 0.33micrograms (to match the dosing scale on injector pen). During the first cycle, the maximum dose is 12micrograms.
Therapy should start on day 2 or 3 of menstrual bleeding and continue until sufficient follicular development (three or more follicles at 17mm or greater). This is usually achieved in five to twenty days. Recombinant human chorionic gonadotropin (hCG) is then to be administered as a single 250microgram (5,000 international units) injection to achieve final follicle maturation. In the event of excessive follicular development, follitropin delta should be stopped and hCG should not be given.
If subsequent cycles are required, dose should be modified or maintained with regard to the ovarian response in the previous cycle. In the event of ovarian hypo-response, the daily dose should be increased by 25% to 50%, according to the response seen previously. In the event of ovarian hyper-response, the daily dose should be decreased by 20% to 33% in the subsequent cycle. In patients who developed ovarian hyperstimulation syndrome (OHSS), the dose should be 33% lower than the dose which caused the OHSS.
The maximum dose is 24 micrograms.
For subcutaneous injection, preferably into the abdominal wall. Patients must be educated on how to self inject and on how to use follitropin delta, after the first injection which should be performed under medical supervision.
Non-polycystic ovarian cyst
Non-polycystic ovarian enlargement
Primary ovarian failure
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Predisposition to thromboembolic disease
History of ovarian hyperstimulation syndrome
Moderate hepatic impairment
Moderate renal impairment
Polycystic ovarian syndrome
Increased risk of ovarian torsion
Treatment to be initiated and supervised by a specialist
Monitor follicular development prior to and during treatment
Monitor ovarian response using ultrasound prior to and during treatment
If pregnancy occurs possibility of ectopic pregnancy should be considered
Monitor estradiol levels during treatment
Ovarian hyperstimulation syndrome can occur
Pregnancy: Increased risk of multiple pregnancies
Discontinue if excessive follicular development occurs
In cases of OHSS withhold hCG & use barrier contraception for 4 days
Prior to initiating therapy, the couples infertility should be assessed, and putative contraindications for pregnancy evaluated.
There is an increased risk of adverse maternal and perinatal outcomes with multiple pregnancies. During assisted reproductive therapies, the risk of multiple pregnancy is mainly related to the number of embryos replaced, embryo quality and patient age. Patients should be educated on the potential risk of multiple births before initiating treatment. The incidence of miscarriage or abortion is higher in patients undergoing controlled ovarian stimulation compared to natural conception. Additionally, the occurrence of congenital malformations after assisted reproductive technologies may be slightly higher than after spontaneous conceptions which may be due to differences in parental characteristics (including maternal age, sperm characteristics) and multiple pregnancy.
Ovarian torsion has been reported in patients undergoing assisted reproductive technology cycles. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Ovarian hyperstimulation syndrome (OHSS)
Minor ovarian enlargement is considered normal during therapy, and usually regresses upon discontinuation of follitropin delta. OHSS is more commonly seen in patients with polycystic ovarian syndrome and is a condition that can manifest itself, with varying degrees of severity.
Frequent and careful monitoring can reduce the risk of OHSS. Symptoms which may indicate OHSS are: severe ovarian enlargement, dyspnoea, oliguria, abdominal pain, discomfort and distension, weight gain and gastrointestinal symptoms including nausea, vomiting and diarrhoea. Clinical assessment may reveal hypovolaemia, electrolyte imbalances, haemoconcentration, haemoperitoneum, ascites, hydrothorax, pleural effusions or acute pulmonary distress. Severe OHSS may be complicated by ovarian torsion or thromboembolic events.
OHSS rarely results from gonadotropin therapy alone, unless hCG is administered to trigger final follicular maturation. Consequently, if ovarian hyperstimulation does occur, hCG should not be administered. The patient should also refrain from coitus or use a barrier contraceptive for at least 4 days.
OHSS often occurs after therapy has been withdrawn. Additionally, OHSS may occur during pregnancy, due to the hormonal changes. Consequently, patients should be followed for a least two weeks after triggering of final follicular maturation.
Pregnancy and Lactation
Follitropin delta is not indicated during pregnancy.
The manufacturer does not recommend using follitropin delta during pregnancy.
Animal studies have shown reproductive toxicity at doses above the recommended maximal dose in humans. In clinical use with gonadotropins, no teratogenic risk has been reported following controlled ovarian stimulation.
Follitropin delta is not indicated during breastfeeding.
The manufacturer suggests that follitropin delta is not indicated during breastfeeding.
Adnexa uteri pain
Changes in mood
Ovarian hyperstimulation syndrome (OHSS)
Last Full Review Date: August 2019
Summary of Product Characteristics: Rekovelle Solution for Injection cartridge, 12mcg, 36mcg, 72mcg. Ferring Pharmaceuticals Ltd. Revised December 2016.
Summary of Product Characteristics: Rekovelle Solution for Injection pre-filled pen, 12mcg, 36mcg, 72mcg. Ferring Pharmaceuticals Ltd. Revised May 2017.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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