Ovaleap (Follitropin Alfa)
Complete patient guide for uses, dosage, side effects, and safety information
Quick 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 like IVF. In men: used with hCG to stimulate sperm production in cases of hypogonadotrophic hypogonadism.
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®.
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How to Take Ovaleap
Ovaleap is given as a course of daily injections under the skin. 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 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 450 IU (33 microgram). Men: commonly 150 IU (11 microgram) three times weekly with hCG. Inject at the same time each day in lower abdomen or thigh, changing injection sites daily.
What If You Miss a Dose?
If you forget an injection or are unsure 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.
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
- diarrhea
- 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, breathing difficulties, severe skin rash)
- signs of stroke or heart attack
- blood clots (pain, warmth, redness, numbness in arms or legs)
- severe OHSS (severe abdominal/pelvic pain, rapid weight gain, reduced urination, breathing difficulties)
- ectopic pregnancy
Important Warnings
There are several important conditions and situations where Ovaleap should not be used. Always discuss your complete medical history with your doctor.
Who Should Not Take Ovaleap
Do not use if allergic to follitropin alfa or any ingredients; have tumors of hypothalamus or pituitary gland. Women: if pregnant, breastfeeding, have enlarged ovaries, unexplained ovarian cysts, unexplained vaginal/uterine bleeding, cancer of ovaries/uterus/breasts, ovarian failure, or uterine fibroids making pregnancy impossible. Men: if have elevated gonadotrophin levels indicating testicular failure, or infertility due to causes other than hypogonadotrophic hypogonadism.
Medical Conditions to Discuss
Tell your doctor if you have thyroid disorders, adrenal gland disorders, high prolactin levels, porphyria or family history of porphyria. Women may be at increased risk of ovarian hyperstimulation syndrome (OHSS), multiple pregnancies, pregnancy loss, birth defects, and blood clots.
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, or are breastfeeding.
OHSS Risk: Women may develop ovarian hyperstimulation syndrome – watch for severe lower abdominal pain, nausea, vomiting, rapid weight gain, and breathing difficulties.
Drug Interactions
Some medicines may interfere with Ovaleap and affect how it works. Always inform your healthcare providers about all medications you are taking.
Alcohol & Driving
Be cautious with activities requiring alertness and inform your doctor about alcohol consumption.
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
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, then must be discarded. After first use with pen, store below 25°C for maximum 28 days with cap on. Discard 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 you feel fine.
Frequently Asked Questions
Treatment length varies for each patient. Women may have more than one treatment cycle, while men typically need combination treatment with hCG 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 after proper training. Your doctor or nurse will teach you the 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 injection sites daily to reduce possible reactions. Avoid areas with lumps, firm knots, depressions, pain, or discoloration.
Contact your doctor or nurse immediately for advice if you forget an injection. Do not inject a double dose on any day. Ovaleap should be used regularly at the same time each day.
Tell your doctor if you drink alcohol. The medication guide advises discussing alcohol consumption with your healthcare provider.
Watch for severe lower abdominal pain, severe pelvic pain, nausea, vomiting, diarrhea followed by rapid weight gain, reduced amounts of urine, and shortness of breath. Contact your doctor immediately if these occur.
Store in original package at 2°C to 8°C (refrigerate, do not freeze) and protect from light. If refrigeration is unavailable, it can be stored below 25°C for up to 3 months, then must be discarded.
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.