Follitropin alfa and lutropin alfa parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of follitropin alfa with lutropin alfa.
These products have been produced by recombinant technology using chinese hamster ovary (CHO) cell lines.
Drugs List
Therapeutic Indications
Uses
Stimulation of follicular development in severe LH and FSH deficiency
Dosage
Adults
The initial dosage regimen is 1 dose (150 unit + 75 unit) daily.
If a dose increase is required, adjustments should be made after 7 to 14 day intervals and preferably in increments of 37.5 to 75 units using a licensed follitropin alfa preparation. The duration of stimulation in a single cycle may be increased to a maximum of 5 weeks if required.
Administration
For subcutaneous administration only.
Contraindications
Uterine cancer
Breast cancer
Breastfeeding
Hypothalamic neoplasm
Non-polycystic ovarian cyst
Non-polycystic ovarian enlargement
Ovarian carcinoma
Pituitary neoplasm
Pregnancy
Primary ovarian failure
Undiagnosed gynaecological haemorrhage
Uterine fibroids
Precautions and Warnings
Family history of porphyria
Predisposition to thromboembolic disease
Polycystic ovarian syndrome
Porphyria
Thromboembolic disorder
Exclude pregnancy incompatible sex organs malformation before initiation
Increased risk of ovarian torsion
Treat other endocrine disorders and causes of infertility first
Treatment to be initiated and supervised by a specialist
May contain polysorbate
Preparation contains sucrose
Record name and batch number of administered product
Monitor ovarian response using ultrasound prior to and during treatment
If pregnancy occurs possibility of ectopic pregnancy should be considered
Monitor closely patient with porphyria during therapy
Monitor estradiol levels during treatment
Advise patient to report any abdominal or pelvic pain
Consider discontinuation if first occurrence/worsening of porphyria occurs
Ovarian hyperstimulation syndrome can occur
Pregnancy: Increased risk of multiple pregnancies
Discontinue immediately if ovarian hyperstimulation occurs
In cases of OHSS withhold hCG & use barrier contraception for 4 days
Luteal phase support should be provided in accordance to local practice
Independent risk factors associated with ovarian hyperstimulation syndrome (OHSS) include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol level, previous episodes of OHSS and large number of developing ovarian follicles.
Reports of ovarian torsion has been observed after treatment with other gonadotropins. Associated risk factors include OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovarian syndrome.
Pregnancy and Lactation
Pregnancy
Follitropin alfa with lutropin alfa is contraindicated during pregnancy.
The manufacturer states that due to limited data, teratogenic effects cannot be excluded during pregnancy. No adverse reactions were observed during human pregnancy and animal studies have not shown an increased risk of teratogenic effects.
Lactation
Follitropin alfa with lutropin alfa is contraindicated during breastfeeding.
The manufacturer states that follitropin alfa with lutropin alfa is not indicated for use during breastfeeding.
Side Effects
Abdominal pain
Anaphylactic reaction
Breast pain
Diarrhoea
Exacerbation of pre-existing asthma
Headache
Hypersensitivity reactions
Increased risk of ectopic pregnancy
Increased risk of multiple pregnancy
Injection site reactions
Nausea
Ovarian cysts
Ovarian hyperstimulation syndrome (OHSS)
Ovarian torsion
Pelvic pain
Shock
Thromboembolic disorders
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2020
Reference Sources
Summary of Product Characteristics: Pergoveris 150 IU/75 IU powder and solvent for solution for injection. Merck Serono. Revised August 2018.
Summary of Product Characteristics: Pergoveris (300 IU + 150 IU)/0.48mL solution for injection in pre-filled pen. Merck Serono. Revised August 2018.
Summary of Product Characteristics: Pergoveris (900 IU + 450 IU)/1.44mL solution for injection in pre-filled pen. Merck Serono. Revised August 2018.
Summary of Product Characteristics: Pergoveris 450IU Pen. Merck Serono. Revised December 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 07 July 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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