Ovaleap (FOLLITROPIN ALFA)

Ovaleap (FOLLITROPIN ALFA) Uses, Dosage, Side Effects, Food Interaction and all others data.

FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.

Used for the treatment of female infertility, urofollitropin or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of urofollitropin is the primary hormone responsible for follicular recruitment and development.

Ovaleap (FOLLITROPIN ALFA)
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Ovaleap (FOLLITROPIN ALFA)
Availability	Prescription only
Generic	Urofollitropin
Urofollitropin Other Names	Follitropin human, Urofollitrophin, Urofollitropin
Related Drugs	progesterone, clomiphene, Clomid, chorionic gonadotropin (hcg), Pregnyl, Menopur, Gonal-f, Follistim, Follistim AQ
Type
Formula	C₄₂H₆₅N₁₁O₁₂S₂
Weight	980.162 Da
Groups	Approved, Vet approved
Therapeutic Class	Trophic Hormones & Related Synthetic Drugs
Manufacturer
Available Country	Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom
Last Updated:	September 19, 2023 at 7:00 am

Uses

Ovaleap (FOLLITROPIN ALFA) lyophilized powder for injection containing 82.5 International Units of FSH, to deliver 75 International Units FSH after reconstituting, supplied as lyophilized powder in sterile vials with diluent vials

Ovaleap (FOLLITROPIN ALFA) is a gonadotropin used for:

Induction of ovulation in women who have previously received pituitary suppression: intramuscular and subcutaneous administration
Development of multiple follicles as part of an Assisted Reproductive Technology (ART) cycle in ovulatory women who have previously received pituitary suppression

Ovaleap (FOLLITROPIN ALFA) is also used to associated treatment for these conditions: Infertility, Assisted Reproductive Technology therapy, Ovulation induction therapy

How Ovaleap (FOLLITROPIN ALFA) works

Dosage

Ovaleap (FOLLITROPIN ALFA) dosage

Ovulation Induction:

Initial starting 150 International Units per day for 5 days, administered subcutaneously or intramuscularly
Individualization of dosing after 5 days
Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150. International Units per adjustment
Do not administer greater than 450 International Units per day

Assisted Reproductive Technology (ART):

Initial starting dose of the first cycle-225 International Units per day for 5 days, administered subcutaneously
Individualization of dosing after 5 days
Dosage adjustments not to occur more frequently than once every 2 days and not to exceed 75 to 150. International Units per adjustment
Do not administer greater than 450 International Units per day

Side Effects

The most common adverse reactions (≥5% incidence) in ovulation induction include headache, hot flashes, OHSS, pain, and respiratory disorder.

The most common adverse reactions (≥2% incidence) in ART include: abdominal cramps, abdominal fullness/enlargement, headache, nausea, OHSS, pain, pelvic pain, and post retrieval pain

Precaution

Abnormal Ovarian Enlargement
Ovarian Hyperstimulation Syndrome
Pulmonary and Vascular Complications
Ovarian Torsion
Multi-fetal Gestation and Birth
Congenital Malformations
Ectopic Pregnancy
Spontaneous Abortion
Ovarian Neoplasms

Interaction

No drug/drug interaction studies have been conducted for Ovaleap (FOLLITROPIN ALFA) in humans

Food Interaction

No interactions found.

Ovaleap (FOLLITROPIN ALFA) Disease Interaction

Major: adrenal dysfunction, thyroid dysfunction, tumors, thromboembolism, intracranial tumorsModerate: pulmonary conditions

Volume of Distribution

Time to peak in plasma: IM: 17 hours (single dose), 11 hours (multiple doses) SubQ: 21 hours (single dose), 10 hours (multiple doses)

Elimination Route

74%

Half Life

Circulation half life of 3-4 hours, elimination half life of 35-40 hours

Elimination Route

Via liver and kidneys

Pregnancy & Breastfeeding use

Pregnancy Category X. Do not use Ovaleap (FOLLITROPIN ALFA) in pregnant women. It is not known whether Ovaleap (FOLLITROPIN ALFA) is excreted in human milk

Contraindication

Ovaleap (FOLLITROPIN ALFA) is contraindicated in women who exhibit:

Prior hypersensitivity to urofollitropins
High levels of FSH indicating primary ovarian failure
Pregnancy
Presence of uncontrolled non-gonadal endocrinopathies
Sex hormone dependent tumors of the reproductive tract and accessory organ
Tumors of pituitary gland or hypothalamus
Abnormal uterine bleeding of undetermined origin
Ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome

Special Warning

Pediatric Use: Safety and efficacy not established.

Renal and Hepatic Insufficiency: Safety, efficacy, and pharmacokinetics of Urofollitrophin in women with renal or hepatic insufficiency have not been established.

Storage Condition

Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C). Protect from light. Use immediately after reconstitution. Discard unused material.

Innovators Monograph

You find simplified version here Ovaleap (FOLLITROPIN ALFA)

FAQ

What is Ovaleap (FOLLITROPIN ALFA) used for?

Ovaleap (FOLLITROPIN ALFA) injection is used to treat infertility in women. This medicine is a man-made hormone called follicle-stimulating hormone.follicle-stimulating hormone is produced in the body by the pituitary gland.follicle-stimulating hormone helps to develop eggs in the ovaries of women.

What are the common side effects of Ovaleap (FOLLITROPIN ALFA)?

May common side effects are include;

stomach pain, bloating;

nausea, vomiting, diarrhea;

rapid weight gain, especially in your face and midsection;

little or no urinating; or

pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down)

Is Ovaleap (FOLLITROPIN ALFA) safe during pregnancy?

Do not use Ovaleap (FOLLITROPIN ALFA) if you are pregnant. Ovaleap (FOLLITROPIN ALFA) may also increase your risk of tubal pregnancy

When should not I take Ovaleap (FOLLITROPIN ALFA)?

You should not use Ovaleap (FOLLITROPIN ALFA) if you have primary ovarian failure, abnormal vaginal bleeding, uncontrolled thyroid or adrenal gland disorders, an ovarian cyst, breast cancer, uterine or ovarian cancer, a pituitary gland tumor, or infertility that is not caused by lack of ovulation.

How do I take Ovaleap (FOLLITROPIN ALFA)?

Inject Ovaleap (FOLLITROPIN ALFA) under the skin or into a muscle, usually once a day or as directed by your doctor. The dosage and length of treatment are based on your medical condition, response to treatment, laboratory tests, and other medications you may be taking.

Is Ovaleap (FOLLITROPIN ALFA) safe during breastfeeding?

It is not known whether Ovaleap (FOLLITROPIN ALFA) passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I use Ovaleap (FOLLITROPIN ALFA)?

Ovaleap (FOLLITROPIN ALFA) is usually given in combination with a medication called human chorionic gonadotropin. This medication causes ovulation to occur by mimicking a natural hormone called luteinizing hormone .

Who should not take Ovaleap (FOLLITROPIN ALFA)?

Do not use Ovaleap (FOLLITROPIN ALFA) if you:

are allergic to urofollitropin or any ingredients of this medication
are infertile for any other cause than lack of follicular development or ovulation (unless you are a candidate for IVF)
are pregnant or breast-feeding
have abnormal uterine bleeding of unknown cause
have an ovarian cyst or enlargement not due to polycystic ovary syndrome
have certain brain lesions (such as a pituitary tumour)
have high levels of FSH
have tumours of the reproductive tract that depend on sex hormones
have uncontrolled thyroid or adrenal dysfunction

Does Ovaleap (FOLLITROPIN ALFA) causes allergic reactions?

This medication may cause a serious allergic reaction in some people. If you develop hives, difficulty breathing, or swelling of the face or throat, stop using the medication and seek medical attention immediately.

Is Ovaleap (FOLLITROPIN ALFA) safe during breastfeeding?

It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are taking Ovaleap (FOLLITROPIN ALFA), it may affect your baby. This medication should not be used by breast-feeding women.