Pergoveris

Pergoveris

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Full Prescribing Info
Contents
Follitropin α, lutropin α.
Description
Vial: Each vial of powder for injection contains follitropin α (r-hFSH) 150 IU (equivalent to 11 mcg) and lutropin α (r-hLH) 75 IU (equivalent to 3 mcg).
Each mL of reconstituted solution contains r-hFSH 150 IU and r-hLH 75 IU. Pergoveris also contains the following excipients: Powder: Sucrose, polysorbate 20, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, concentrated phosphoric acid and sodium hydroxide for pH adjustment. Solvent: Water for injections.
Follitropin α and lutropin α are produced in genetically engineered Chinese hamster ovary (CHO) cells.
Pre-filled pen: Each multidose pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa* (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa* (r-hLH) in 0.48 mL solution.
Each multidose pre-filled pen contains 450 IU (equivalent to 33 micrograms) of follitropin alfa* (r-hFSH) and 225 IU (equivalent to 9 micrograms) of lutropin alfa* (r-hLH) in 0.72 mL solution.
Each multidose pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa* (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa* (r-hLH) in 1.44 mL solution.
*recombinant human follitropin alfa and recombinant human lutropin alfa are produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
The pH of the solution is 6.5 - 7.5, its osmolality is 250 - 400 mOsm/kg.
Excipients/Inactive Ingredients: Pre-filled pen: Sucrose, Arginine monohydrochloride, Poloxamer 188, Methionine, Phenol, Disodium phosphate dihydrate, Sodium dihydrogen phosphate monohydrate, Sodium hydroxide (for pH adjustment), Concentrated phosphoric acid (for pH adjustment), Water for injections.
Action
Pharmacotherapeutic Group: Vial: Gonadotropins. Pre-filled pen: Sex hormones and modulators of the genital system, gonadotropins. ATC Code: Vial: G03GA05/G03GA07. Pre-filled pen: G03GA30.
Pharmacology: Pharmacodynamics: Vial: Pergoveris is a preparation of follicle-stimulating hormone (FSH) and luteinising hormone (LH) produced by genetically engineered Chinese hamster ovary (CHO) cells.
Pre-filled pen: Pergoveris is a preparation of recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Mechanism of action: In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism.
In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.
Clinical efficacy: In one clinical study of women with hypogonadotropic hypogonadism and an endogenous serum LH concentration below 1.2 IU/L the appropriate dose of r-hLH was investigated. A dose of 75 IU r-hLH daily (in combination with 150 IU r-hFSH) resulted in adequate follicular development and oestrogen production. A dose of 25 IU r-hLH daily (in combination with 150 IU r-hFSH) resulted in insufficient follicular development.
Vial: Therefore, administration of <1 vial of Pergoveris daily may provide too little LH activity to ensure adequate follicular development.
Pre-filled pen: Therefore, administration of Pergoveris containing less than 75 IU r-hLH daily may provide too little LH-activity to ensure adequate follicular development.
Pharmacokinetics: Follitropin alfa and lutropin alfa have shown the same pharmacokinetic profile as follitropin alfa and lutropin alfa separately.
Follitropin alfa: Distribution: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Vial: The steady-state volume of distribution and total clearance are 10 L and 0.6 L/hr, respectively. One-eighth (1/8) of the r-hFSH dose is excreted in the urine.
Pre-filled pen: The steady state volume of distribution is 10 L.
Following subcutaneous administration, the absolute bioavailability is about 70%. Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady state within 3-4 days. In women whose endogenous gonadotropin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Elimination: Pre-filled pen: Total clearance is 0.6 L/h and one-eighth of the follitropin alfa dose is excreted in the urine.
Lutropin alfa: Distribution: Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour and eliminated from the body with a terminal half-life of about 10-12 hours. The steady-state volume of distribution is around 10-14 L. Lutropin alfa shows linear pharmacokinetics, as assessed by AUC which is directly proportional to the dose administered.
Vial: Total clearance is around 2 L/hr and <5% of the dose is excreted in the urine. The mean residence time is approximately 5 hrs.
Following subcutaneous administration, the absolute bioavailability is approximately 60%; the terminal half-life is slightly prolonged. The lutropin alfa pharmacokinetics following single and repeated administration of lutropin alfa are comparable and the accumulation ratio of lutropin alfa is minimal.
Vial: There is no pharmacokinetic interaction with r-hFSH when administered simultaneously.
Pre-filled pen: The mean residence time is approximately 5 hours.
Elimination: Pre-filled pen: Total clearance is around 2 L/h, and less than 5% of the dose is excreted in the urine.
Pharmacokinetic/pharmacodynamic relationships: Pre-filled pen: There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Clinical studies with Pergoveris were conducted with a freeze-dried formulation. A comparative clinical study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Toxicology: Preclinical safety data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity.
Indications/Uses
Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.
In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Dosage/Direction for Use
Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Posology: In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Pergoveris therapy is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotropin (hCG). Pergoveris should be given as a course of daily injections. Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and oestrogen response.
Vial: A recommended regimen commences with 1 vial of Pergoveris daily. If <1 vial of Pergoveris daily is used, the follicular response may be unsatisfactory because the amount of lutropin α (r-hLH) may be insufficient (see Pharmacology: Pharmacodynamics under Actions).
Pre-filled pen: A treatment regimen commences with the recommended dose of Pergoveris containing 150 IU r-hFSH/75 IU r-hLH daily. If less than the recommended dose daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see Pharmacology: Pharmacodynamics under Actions).
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7- to 14-day intervals and preferably by 37.5-75 IU increments using a licensed follitropin alfa preparation. It may be acceptable to extend the duration of stimulation in any one cycle up to 5 weeks.
Vial: When an optimal response is obtained, a single injection of 5000-10,000 IU hCG should be administered 24-48 hrs after the last Pergoveris injection.
Pre-filled pen: When an optimal response is obtained, a single injection of 250 micrograms of r-hCG or 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Pergoveris injection. The patient is recommended to have coitus on the day of, and on the day following hCG administration. Alternatively, intrauterine insemination (IUI) may be performed.
Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
If an excessive response is obtained, treatment should be stopped and hCG withheld. Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/L as measured in a central laboratory. However, it should be taken into account that there are variations between LH measurements performed in different laboratories. In these trials, the ovulation rate/cycle was 70-75%.
Special populations: Pre-filled pen: Elderly: There is no relevant indication for the use of Pergoveris in the elderly population. Safety and effectiveness of this medicinal product in elderly patients have not been established.
Renal and hepatic impairment: Safety, efficacy, and pharmacokinetics of this medicinal product in patients with renal or hepatic impairment have not been established.
Paediatric population: There is no relevant use of this medicinal product in the paediatric population.
Method of administration: Vial: Pergoveris is intended for SC administration. The powder should be reconstituted immediately prior to use with the solvent provided.
Pre-filled pen: Pergoveris is intended for subcutaneous administration. The first injection should be performed under direct medical supervision. Self-administration should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
For instructions on the use of this medicinal product, see Special precautions for disposal and other handling under Cautions for Usage.
Overdosage
Symptoms: The effects of an overdose of Pergoveris are unknown. Nevertheless there is a possibility that OHSS may occur, which is further described in Precautions.
Management: Pre-filled pen: Treatment is directed to symptoms.
Contraindications
Pergoveris is contraindicated in patients with: hypersensitivity to the active substances or to any of the excipients listed in Description; tumours of the hypothalamus and pituitary gland; ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin; gynaecological haemorrhages of unknown origin; ovarian, uterine or mammary carcinoma.
Pergoveris must not be used when an effective response cannot be obtained, such as: primary ovarian failure; malformations of sexual organs incompatible with pregnancy; fibroid tumours of the uterus incompatible with pregnancy.
Use in pregnancy & lactation: Vial: Pergoveris should not be used during pregnancy or lactation.
Special Precautions
Pergoveris contains potent gonadotropic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of Pergoveris calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women.
Vial: Self-administration of Pergoveris should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
The 1st injection of Pergoveris should be performed under direct medical supervision.
Pergoveris contains sucrose 30 mg/dose. This should be taken into account in patients with diabetes mellitus.
Porphyria: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris.
Pre-filled pen: In these patients, Pergoveris may increase the risk of an acute attack.
Deterioration or a first appearance of this condition may require cessation of treatment.
Treatment in women: Vial: 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 the following: Hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours.
Appropriate specific treatment should be given.
Pre-filled pen: 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 appropriate specific treatment should be given.
Patients undergoing stimulation of follicular growth are at an increased risk of developing hyperstimulation in view of possible excessive oestrogen response and multiple follicular development.
Ovarian hyperstimulation syndrome (OHSS): Vial: In clinical trials, lutropin α in combination with follitropin α has been shown to increase the ovarian sensitivity to gonadotropins. If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7- to 14-day intervals and preferably with 37.5-75 IU increments using a licensed follitropin α preparation.
Ovarian hyperstimulation syndrome (OHSS) is a medical event distinct from uncomplicated ovarian enlargement. It is a syndrome that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress, and thromboembolic events.
Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.
Excessive ovarian response seldom gives rise to significant hyperstimulation unless human chorionic gonadotropin (hCG ) is administered to induce ovulation. Therefore, in cases of ovarian hyperstimulation, it is prudent to withhold hCG in such cases and advise the patient to refrain from coitus or use barrier methods for at least 4 days. OHSS may progress rapidly (within 24 hrs to several days) to become a serious medical event, therefore, patients should be followed for at least 2 weeks after hCG administration.
To minimise the risk of OHSS or of multiple pregnancy (see text as follows), ultrasound scans as well as oestradiol measurements are recommended. In anovulation, the risk of OHSS is increased by a serum oestradiol level >900 pg/mL (3300 pmol/L) and by the presence of >3 follicles of ≥14 mm in diameter.
Adherence to recommended Pergoveris and FSH dosage and regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see text as follows).
Ovarian hyperstimulation syndrome may be more severe and more protracted if pregnancy occurs. Most often, OHSS occurs after hormonal treatment has been discontinued and reaches its maximum at about 7-10 days following treatment. Usually, OHSS resolves spontaneously with the onset of menses.
If severe OHSS occurs, gonadotropin treatment should be stopped if still ongoing. The patient should be hospitalised and specific therapy for OHSS started.
This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
When risk of OHSS or multiple pregnancies is assumed, treatment discontinuation should be considered.
Pre-filled pen: A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment.
In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress, and thromboembolic events. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotrophins, high absolute or rapidly rising serum oestradiol level (> 900 pg/mL or > 3,300 pmol/L in anovulation), previous episodes of OHSS and large number of developing ovarian follicles (3 follicles of ≥ 14 mm in diameter in anovulation).
Adherence to recommended Pergoveris and FSH dosage and regimen of administration can minimise the risk of ovarian hyperstimulation. Monitoring of stimulation cycles by ultrasound scans as well as oestradiol measurements are recommended to early identify risk factors.
There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs. Therefore, if signs of OHSS occur such as serum oestradiol level > 5,500 pg/mL or > 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days. OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event. It most often occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. Therefore patients should be followed for at least two weeks after hCG administration.
If severe OHSS occurs, gonadotropin treatment should be stopped if still ongoing. The patient should be hospitalised and specific therapy for OHSS started. This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
When a risk of OHSS is assumed, treatment discontinuation should be considered.
Ovarian torsion: Pre-filled pen: Ovarian torsion has been reported after treatment with other gonadotropins. This may be associated with other risk factors such as OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovarian syndrome. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multiple pregnancy: In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception. The majority of multiple conceptions are twins.
Pre-filled pen: Multiple pregnancy, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
The patients should be advised of the potential risk of multiple births before starting treatment. When risk of multiple pregnancies is assumed, treatment discontinuation should be considered.
Pregnancy loss: Vial: The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction than in the normal population.
Pre-filled pen: The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction than in the normal population.
Ectopic pregnancy: Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
Vial: The prevalence of ectopic pregnancy after IVF was reported to be 2-5%, as compared to 1-1.5% in the general population.
Pre-filled pen: The prevalence of ectopic pregnancy after assisted reproductive technologies (ART) was reported to be higher than in general population.
Reproductive system neoplasms: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established whether or not treatment with gonadotropins increases the baseline risk of these tumours in infertile women.
Congenital malformation: The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Thromboembolic events: Vial: In women with generally recognised risk factors for thromboembolic events eg, personal or family history, treatment with gonadotropins may further increase the risk. In these women, the benefits of gonadotropin administration need to be weighed against the risks. It should be noted however, that pregnancy itself also carries an increased risk of thromboembolic events.
Pre-filled syringe: In women with recent or ongoing thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, thrombophilia or severe obesity (body mass index > 30 kg/m2), treatment with gonadotrophins may further increase the risk. In these women, the benefits of gonadotrophin administration need to be weighed against the risks. It should be noted however, that pregnancy itself as well as OHSS also carries an increased risk of thromboembolic events.
Sodium: Pergoveris contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially "sodium-free".
Effects on ability to drive and use machines: Vial: No studies on the effects on the ability to drive and use machines have been performed.
Pre-filled pen: Pergoveris has no or negligible influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
Vial: Pergoveris should not be used during pregnancy or lactation.
Pre-filled pen: Pregnancy: There is no indication for the use of Pergoveris during pregnancy. Data on a limited number of exposed pregnancies indicate no adverse reactions of follitropin alfa and lutropin alfa on pregnancy, embryonal or foetal development, parturition or postnatal development following controlled ovarian stimulation. No teratogenic effect of such gonadotropins has been reported in animal studies. In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of Pergoveris.
Breast-feeding: Pergoveris is not indicated during breast-feeding.
Fertility: Pergoveris is indicated for use in infertility (see Indications).
Adverse Reactions
Vial: Within each frequency grouping, adverse effects are presented in order of decreasing seriousness.
Frequency is defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000).
Nervous System Disorders: Very Common: Headache. Common: Somnolence.
Respiratory, Thoracic and Mediastinal Disorders: Very Rare: Exacerbation or worsening of asthma.
Gastrointestinal Disorders: Common: Abdominal pain and gastrointestinal symptoms eg, nausea, vomiting, diarrhoea, abdominal cramps and bloating.
Vascular Disorders: Very Rare: Thromboembolism, usually associated with severe ovarian hyperstimulation syndrome (OHSS).
General Disorders and Administration Site Conditions: Very Common: Mild to severe injection site reaction (pain, redness, bruising, swelling and/or irritation at the site of injection).
Immune System Disorders: Very Rare: Mild systemic allergic reactions (eg, mild forms of erythema, rash, facial swelling, urticaria, oedema, difficulty in breathing). Serious cases of allergic reactions, including anaphylactic reactions have also been reported.
Reproductive System and Breast Disorders: Very Common: Ovarian cysts. Common: Breast and pelvic pain, mild to moderate OHSS. Uncommon: Severe OHSS. Rare: Ovarian torsion, a complication of OHSS.
Pre-filled pen: Summary of the safety profile: The most commonly reported adverse reactions are headache, ovarian cysts and local injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection).
Mild or moderate OHSS has been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. Severe OHSS is uncommon (see Precautions).
Thromboembolism may occur very rarely, usually associated with severe OHSS (see Precautions).
Tabulated list of adverse reactions: The frequency categories used are: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Immune system disorders: Very rare: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock.
Nervous system disorders: Very common: Headache.
Vascular disorders: Very rare: Thromboembolism, usually associated with severe OHSS.
Respiratory, thoracic and mediastinal disorders: Very rare: Exacerbation or aggravation of asthma.
Gastrointestinal disorders: Common: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea.
Reproductive system and breast disorders: Very common: Ovarian cysts.
Common: Breast pain, pelvic pain, mild or moderate OHSS (including associated symptomatology).
Uncommon: Severe OHSS (including associated symptomatology) (see Precautions).
Rare: Complication of severe OHSS.
General disorders and administration site conditions: Very common: Mild to severe injection site reactions (e.g. pain, erythema, haematoma, bruising, swelling and/or irritation at the site of injection).
Drug Interactions
Pre-filled pen: Pergoveris solution for injection in pre-filled pen must not be administered as a mixture with other medicinal products in the same injection.
Pergoveris solution for injection in pre-filled pen may be administered concomitantly with a licensed follitropin alfa preparation as separate injections.
Caution For Usage
Instructions for Use, Handling and Disposal: Vial: For single use only.
Pergoveris must be reconstituted with the solvent before use.
The reconstituted solution should not be administered if it contains particles or is not clear.
Pergoveris may be mixed with follitropin α and co-administered as a single injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
For administration, carefully read the following instructions: Wash hands. It is important that hands and the items to be used are as clean as possible.
Assemble and lay out on a clean surface everything needed: One vial containing Pergoveris powder, 1 solvent vial, 2 alcohol swabs, 1 syringe, 1 needle for reconstitution and a fine-bore needle for SC injection, sharp container.
Remove the protective cap from the solvent vial. Attach the reconstitution needle to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1-mL mark. Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent. Set the syringe down carefully on the work-surface taking care not to touch the needle.
Prepare the injection solution. Remove the protective cap from the Pergoveris powder vial, pick up the syringe and slowly inject the solvent into the vial of powder. Swirl gently without removing the syringe. Do not shake. After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles. Turn the vial upside down, gently draw the solution back into the syringe.
Change the needle for the fine-bore needle and remove any air bubbles. If air bubbles are seen in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top. Push the plunger until the air bubbles are gone.
Immediately inject the solution. Choose the site of injection (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. 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.
Dispose of all used items. Once finished with the injection, immediately discard all needles and empty glass containers in the sharp container provided. Any unused solution must be discarded.
Pre-filled pen: Special precautions for disposal and other handling: Only clear solution without particles should be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: Vial: Pergoveris must not be mixed with other medicinal products except follitropin α.
Pre-filled pen: Not applicable.
Storage
Vial: Do not store above 30°C. Protect from light.
Pre-filled pen: Store in refrigerator (2°C- 8°C). Do not freeze.
Store in the original package in order to protect from light.
For in-use storage conditions, see Shelf life as follows.
Shelf life: 2 years.
Chemical and physical in-use stability has been demonstrated for 28 days at 30°C.
Once opened, the product may be stored for a maximum of 28 days at 30°C. Other in-use storage times and conditions are the responsibility of the user.
ATC Classification
G03GA30 - combinations ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Powd for inj (vial) 1's. Soln for inj (pre-filled pen) (clear, colourless to slightly yellow) 300 IU + 150 IU x 0.48 mL x 1's. 450 IU + 225 IU x 0.72 mL x 1's. 900 IU + 450 IU x 1.44 mL x 1's.
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