Ovaleap (Follitropin Alfa)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Ovaleap Used For?
Ovaleap contains follitropin alfa, which is similar to follicle stimulating hormone (FSH) found naturally in humans. It belongs to a class of hormones called gonadotrophins and is essential for reproductive health in both men and women.
Primary Uses
In women: stimulates development of follicles in women who do not ovulate and have not responded to clomiphene citrate treatment; stimulates development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as in vitro fertilisation (IVF). In men: used with human chorionic gonadotrophin (hCG) to stimulate sperm production.
How It Works
FSH is necessary for the growth and development of egg cells (follicles) in women and sperm production in men. Ovaleap is an approved biosimilar to the reference product Gonal-f®.
Good to know: Ovaleap is an approved biosimilar medication, meaning it has been proven to work the same way as the original reference medicine.
How to Take Ovaleap
Ovaleap is given as subcutaneous (under the skin) injections in the lower abdominal area or thigh. Your doctor will determine the correct dose for you, and it may be adjusted based on your individual response to treatment.
Dosage Instructions
Women who are not ovulating: Usually starts at 75 IU (5.5 microgram) daily, maximum usually not higher than 225 IU (16.5 microgram). Women undergoing ART: Usually starts at 150 IU (11 microgram) daily on day 2 or 3 of cycle, maximum usually not higher than 450 IU (33 microgram). Men with hypogonadotrophic hypogonadism: Usually 150 IU (11 microgram) three times a week with hCG. Inject at the same time each day, changing injection sites daily to reduce reactions.
What If You Miss a Dose?
If you forget an injection or are not sure what to do, contact your doctor or nurse immediately for advice. Do not inject a double dose on any day.
Important: Never inject a double dose. Always contact your healthcare provider if you miss a dose or are unsure about your injection schedule.
Available Tablet Strengths
Side Effects
Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.
Common Side Effects
These side effects occur relatively frequently and usually don’t require emergency care:
- Injection site reactions (pain, redness, itching, swelling)
- Headache
- Dizziness
- Stomach pain
- Abdominal distension or discomfort
- Nausea
- Vomiting
- Diarrhoea
- Acne (in men)
- Weight gain (in men)
- Breast tissue increase (in men)
- Vaginal bleeding
Seek immediate medical attention if you experience:
- Allergic reactions (swelling of face, lips, tongue; shortness of breath; severe skin rash)
- Signs of stroke or heart attack
- Blood clots (pain, warmth, redness, numbness in arm or leg)
- Inflammation, swelling or pain in legs
- Severe OHSS (severe abdominal/pelvic pain, nausea, vomiting, rapid weight gain, reduced urine, shortness of breath)
- Ectopic pregnancy (especially in women with prior tubal disease)
Important Warnings
There are several important conditions and situations where Ovaleap should not be used. Your doctor will assess your medical history before prescribing this medication.
Who Should Not Take Ovaleap
Do not use if allergic to follitropin alfa or any ingredients; have tumours of hypothalamus or pituitary gland. Women: if pregnant, breastfeeding, have enlarged ovaries, unexplained ovarian cyst, unexplained vaginal/uterine bleeding, cancer of ovaries/uterus/breasts, ovarian failure, or fibroids/malformations making pregnancy impossible. Men: if have increased gonadotrophin levels indicating testicular failure, or infertility due to disorders other than hypogonadotrophic hypogonadism.
Medical Conditions to Discuss
Tell your doctor if you have: thyroid gland disorders, adrenal gland disorders, high prolactin levels in blood, porphyria or family history of porphyria, history of blood clots, or any other medical conditions.
Pregnancy and Breastfeeding
Do not use Ovaleap if you are pregnant or breastfeeding. Check with your doctor if you are pregnant, intend to become pregnant, are breastfeeding, or intend to breastfeed.
OHSS Risk: Treatment may increase risk of ovarian hyperstimulation syndrome (OHSS) in women. Your doctor will monitor you closely with ultrasound and blood tests.
Drug Interactions
Some medicines may interfere with Ovaleap and affect how it works. Always tell your doctor about all medications you are taking.
- Tell your doctor about all medicines, vitamins, or supplements you take
- Check with your doctor if unsure about medication interactions
- Your doctor has information on medicines to be careful with while using Ovaleap
Alcohol & Driving
Be cautious with activities requiring alertness and discuss alcohol consumption with your healthcare provider.
Alcohol
Tell your doctor if you drink alcohol.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how Ovaleap affects you.
Storage
Before use, store Ovaleap in original package at 2°C to 8°C (refrigerate, do not freeze) and protect from light. If refrigeration unavailable, can be stored below 25°C for up to 3 months away from light, but must be discarded after 3 months. After first use with pen, store below 25°C for maximum 28 days with cap on. Do not use if solution contains particles or is not clear.
Overdose Information
If you think you have used too much Ovaleap, seek urgent medical attention immediately. Phone the Poisons Information Centre (13 11 26 in Australia or 0800 764 766 in New Zealand), contact your doctor, or go to the nearest hospital Emergency Department, even if there are no signs of discomfort or poisoning.
Frequently Asked Questions
Treatment length varies with each patient. For women, it’s possible to have more than one treatment cycle. For men, combination treatment with hCG could continue for at least 4 months and may continue for up to 18-24 months.
Yes, Ovaleap is intended to be injected by you or your partner using the Ovaleap Pen. Your doctor or nurse will teach you the proper injection technique, and you should not self-inject until you are sure of how to do it properly.
Inject in the lower abdominal area (except around navel and waistline) or front of your thigh. Change the injection site daily to reduce possible reactions. Do not inject into areas with lumps, firm knots, depressions, pain, or discoloration.
Call your doctor straight away if you become pregnant while using Ovaleap. Do not use Ovaleap if you are pregnant or breastfeeding.
OHSS (ovarian hyperstimulation syndrome) is when ovaries over-react to hormonal treatment and become larger. The most common symptom is lower abdominal pain. Your doctor will monitor you closely with ultrasound and blood tests to help determine if you’re likely to develop OHSS.
Do not stop using this medicine suddenly. Always consult your doctor before making any changes to your treatment plan.
Ovaleap should be used regularly at the same time each day. If you forget an injection or are not sure what to do, contact your doctor or nurse immediately for advice. Do not inject a double dose on any day.
Important Disclaimer
This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.
If you think you may have a medical emergency, call your doctor or emergency services immediately.