Ovidrel

Ovidrel

choriogonadotropin alfa

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Choriogonadotropin α.
Description
A dose of 250 mcg in 0.5 mL is equivalent to approximately 6500 IU.
Choriogonadotropin α is produced by recombinant DNA technology in Chinese hamster ovary cells.
Action
Pharmacotherapeutic Group: Gonadotropin. ATC Code: G03GA08.
Pharmacology: Pharmacodynamics: Ovidrel is a medicinal product of chorionic gonadotropin produced by recombinant DNA techniques. It shares the amino acid sequence with urinary hCG. Chorionic gonadotropin binds on the ovarian theca (and granulosa) cells to a transmembrane receptor shared with the luteinising hormone, the LH/CG receptor.
The principal pharmacodynamic activity in women is oocyte meiosis resumption, follicular rupture (ovulation), corpus luteum formation and production of progesterone and estradiol by the corpus luteum.
In women, chorionic gonadotropin acts as a surrogate LH surge that triggers ovulation.
Ovidrel is used to trigger final follicular maturation and early luteinisation after use of medicinal products for stimulation of follicular growth.
In comparative clinical trials, administration of a dose of Ovidrel 250 mcg was as effective as 5000 and 10,000 IU of urinary hCG in inducing final follicular maturation and early luteinisation in assisted reproductive techniques, and as effective as 5000 IU of urinary hCG in ovulation induction.
So far, there are no signs of antibody development in humans to Ovidrel. Repeated exposure to Ovidrel was investigated in male patients only. Clinical investigation in women for the indication of assisted reproductive techniques (ART) and anovulation was limited to 1 treatment cycle.
Pharmacokinetics: Following IV administration, choriogonadotropin α is distributed to the extracellular fluid space with a distribution half-life of around 4.5 hours. The steady-state volume of distribution and the total clearance are 6 L and 0.2 L/hr, respectively. There are no indications that choriogonadotropin α is metabolised and excreted differently than endogenous hCG.
Following SC administration, choriogonadotropin α is eliminated from the body with a terminal half-life of about 30 hours, and the absolute bioavailability is about 40%.
A comparable study between the freeze-dried formulation and the liquid formulation showed bioequivalence between the 2 formulations.
Toxicology: Preclinical Safety Data: Preclinical safety data reveal no intrinsic toxicity of choriogonadotropin α. Studies on carcinogenic potential were not performed. This is justified, given the proteinous nature of the drug substance and the negative outcome of the genotoxicity testing.
Studies on reproduction were not performed in animals.
Indications/Uses
Treatment of women undergoing superovulation prior to assisted reproductive techniques eg, in vitro fertilisation (IVF): Ovidrel is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth.
Treatment of anovulatory or oligo-ovulatory women: Ovidrel is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.
Dosage/Direction for Use
Ovidrel is intended for SC administration.
Treatment with Ovidrel should be performed under the supervision of a physician experienced in the treatment of fertility problems.
The following dosing regimen should be used: Women undergoing Superovulation Prior to Assisted Reproductive Techniques eg, In vitro Fertilisation (IVF): 1 pre-filled syringe of Ovidrel (250 mcg) is administered 24-48 hrs after the last administration of an FSH or hMG preparation ie, when optimal stimulation of follicular growth is achieved.
Anovulatory or Oligo-Ovulatory Women: 1 pre-filled syringe of Ovidrel (250 mcg) is administered 24-48 hrs after optimal stimulation of follicular growth is achieved. The patient is recommended to have coitus on the day of, and the day after, Ovidrel injection.
Instructions for Use, Handling and Disposal: Ovidrel is given by injection under the skin. Each pre-filled syringe is for single use only. Only clear solution without particles should be used. Any unused product or waste material should be disposed of in accordance with local requirements.
Read the following instructions carefully before self-administering Ovidrel: 1. Wash hands. It is important that hands and the items to be used are as clean as possible.
2. Assemble everything that is needed. Note that alcohol swabs are not contained in the package. Find a clean area and lay out everything: 2 alcohol swabs, 1 pre-filled syringe containing the medicinal product.
3. Injection: Immediately inject the solution. The doctor or nurse will have already advised the patient where to inject (eg, tummy, front of thigh). Wipe the chosen area with an alcohol swab. Firmly pinch the skin together and insert the needle at a 45°-90° angle using a dart-like motion. Inject under the skin, as taught. Do not inject directly into a vein. Inject the solution by pushing gently on the plunger. Take as much time as needed to inject all the solution. Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
4. Dispose of All Used Items: Once injection is finished, immediately discard the empty syringe in a sharps container. Any unused solution must be discarded.
Overdosage
No case of overdosage has been reported.
Nevertheless, there is a possibility that ovarian hyperstimulation syndrome (OHSS) may result from an overdosage of Ovidrel (see Precautions).
Contraindications
Ovidrel is contraindicated for safety reasons in case of: Tumours of the hypothalamus and pituitary gland; hypersensitivity to choriogonadotropin α or to any of the excipients; ovarian enlargement or cyst due to reasons other than polycystic ovarian disease; gynaecological haemorrhages of unknown aetiology; ovarian, uterine or mammary carcinoma; extrauterine pregnancy in the previous 3 months; active thromboembolic disorders.
Ovidrel must not be used when an effective response cannot be obtained eg, primary ovarian failure, malformations of sexual organs incompatible with pregnancy, fibroid tumours of the uterus incompatible with pregnancy, postmenopausal women.
Special Precautions
To date, there is no clinical experience with Ovidrel in other indications commonly treated with urine-derived human chorionic gonadotropin.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Special precautions should be taken before administering Ovidrel to patients with clinically significant systemic disease where pregnancy could lead to a worsening of the condition.
Patients undergoing ovarian stimulation are at an increased risk of developing ovarian hyperstimulation syndrome (OHSS) due to multiple follicular development.
Ovarian hyperstimulation syndrome may become a serious medical event characterised by large ovarian cysts, which are prone to rupture and the presence of ascites within a clinical picture of circulatory dysfunction. Ovarian hyperstimulation syndrome due to excessive ovarian response can be avoided by withholding hCG administration. Patients should be advised to refrain from coitus or use barrier methods for at least 4 days.
Careful monitoring of estradiol levels and ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, for all patients.
The risk of multiple pregnancy following assisted reproductive technologies is related to the number of embryos replaced. In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births (mostly twins) is increased compared with natural conception.
To minimise the risk of OHSS and of multiple pregnancy, ultrasound scans as well as estradiol measurements are recommended. In anovulation, the risk of OHSS is increased by a serum estradiol level >1500 pg/mL (5400 pmol/L) and >3 follicles of ≥14 mm in diameter. In assisted reproductive techniques, there is an increased risk of OHSS with a serum estradiol >3000 pg/mL (11,000 pmol/L) and ≥20 follicles of ≥12 mm in diameter. When the estradiol level is >5500 pg/mL (20,000 pmol/L) and when there are ≥40 follicles in total, it may be necessary to withhold hCG administration.
Adherence to recommended Ovidrel dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy.
The rate of miscarriage, in both anovulatory patients and women undergoing assisted reproductive techniques, is higher than that found in the normal population but comparable with the rates observed in women with other fertility problems.
During Ovidrel therapy, a minor thyroid stimulation is possible, of which the clinical relevance is unknown.
Self-administration of Ovidrel should only be performed by patients who are adequately trained and have access to expert advice.
Effects on the Ability to Drive or Operate Machinery: No studies on the effects on the ability to drive and use machines have been performed.
Use in pregnancy & lactation: Considering the indication, Ovidrel should not be used during pregnancy and lactation. For Ovidrel, no clinical data on exposed pregnancies are available. No reproduction studies with choriogonadotropin α in animals were performed. The potential risk for humans is unknown.
There are no data on the excretion of choriogonadotropin α in milk.
Use In Pregnancy & Lactation
Considering the indication, Ovidrel should not be used during pregnancy and lactation. For Ovidrel, no clinical data on exposed pregnancies are available. No reproduction studies with choriogonadotropin α in animals were performed. The potential risk for humans is unknown.
There are no data on the excretion of choriogonadotropin α in milk.
Adverse Reactions
In comparative trials with different doses of Ovidrel, the following undesirable effects were found to be associated with Ovidrel in a dose-related fashion: Ovarian hyperstimulation syndrome, and vomiting and nausea. Ovarian hyperstimulation syndrome was observed in approximately 4% of patients treated with Ovidrel. Severe ovarian hyperstimulation syndrome was reported in <0.5% patients (see Precautions).
In rare instances, thromboembolisms have been associated with menotrophin/hCG therapy. Although this adverse event was not observed, there is the possibility that this may also occur with Ovidrel.
Ectopic pregnancy, ovarian torsion and other complications have been reported in patients after hCG administration. These are considered concomitant effects related to assisted reproductive technologies (ART).
After best evidence assessment, the following undesirable effects may be observed after administration of Ovidrel.
Common (>1/100, <1/10): Application Site Disorders: Local reaction/pain at injection site.
General Disorders: Headache, tiredness.
Gastrointestinal System Disorders: Vomiting/nausea, abdominal pain.
Reproductive Disorders: Mild or moderate ovarian hyperstimulation syndrome.
Uncommon (>1/1000, <1/100): Psychiatric Disorders: Depression, irritability, restlessness.
Gastrointestinal System Disorders: Diarrhoea.
Reproductive Disorders: Severe ovarian hyperstimulation syndrome, breast pain.
Drug Interactions
No specific interaction studies with Ovidrel and other medicines have been performed. However, no clinically significant drug interactions have been reported during hCG therapy.
Following administration, Ovidrel may interfere for up to 10 days with the immunological determination of serum/urinary hCG, leading to a false-positive pregnancy test.
Incompatibilities: In the absence of incompatibility studies, Ovidrel must not be mixed with other medicinal products.
Storage
Store at 2°-8°C (in a refrigerator). Store in the original package. Within its shelf-life, the solution may be stored at or below 25°C for up to 30 days without being refrigerated again during this period. It must be discarded if not used after 30 days.
Shelf-Life: 2 years.
After opening, Ovidrel should be used immediately. However, the in-use stability has been demonstrated for 24 hrs at 2°-8°C
ATC Classification
G03GA08 - choriogonadotropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Inj (pre-filled syringe) 250 mcg/0.5 mL x 1's.
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