Profasi Uses

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• Profasi indications
• Uses of Profasi in details
• Profasi description
• Profasi dosage
• Profasi interactions
• Profasi side effects
• Profasi contraindications

What is Profasi?

Profasi is a hormone that supports the normal development of an egg in a woman's ovary, and stimulates the release of the egg during ovulation.

HCG is used to cause ovulation and to treat infertility in women, and to increase sperm count in men. HCG is also used in young boys when their testicles have not dropped down into the scrotum normally. This can be caused by a pituitary gland disorder.

HCG may also be used for other purposes not listed.

Profasi indications

Profasi® PreFilled Syringe (Profasi injection) is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Profasi® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Selection Of Patients

1. Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy. Patients with tubal obstruction should receive Profasi® PreFilled Syringe only if enrolled in an in vitro fertilization program.
2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
3. Appropriate evaluation should be performed to exclude pregnancy.
4. Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting FSH and Profasi® PreFilled Syringe therapy.
5. Evaluation of the partner's fertility potential should be included in the initial evaluation.

How should I use Profasi?

Use Profasi as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Profasi is given as an injection under the skin. A health care provider will teach you how to use it. Be sure you understand how to use Profasi. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Profasi comes in a single-use syringe. Wash your hands with soap and water before you begin. Wipe the appropriate injection site with an alcohol swab. Remove the cap from the needle of the syringe. Do not touch the needle or allow the needle to touch anything else. Use the technique you have been shown to give the injection. After giving the injection, cover the injection site with a small bandage if necessary. Discard all used material appropriately.
• Do not use Profasi if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Profasi, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Profasi.

Uses of Profasi in details

This medication is a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. It is also used in certain boys to help with normal sexual development. It works by causing the testes to release male sex hormones (e.g., testosterone).

This medication is also used in women to treat fertility problems. It is given after finishing another medication (menotropins) to cause the release of an egg (ovulation). It should not be used in women whose ovaries no longer make eggs properly (primary ovarian failure).

This medication has not been shown to be effective for weight loss and should not be used for this purpose.

How to use HCG intramuscular

This medication is given by injection into a muscle by a health care professional. If you are giving this medication at home, learn all preparation and usage instructions for this product. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If you have any questions about the use of this medication, ask your doctor or pharmacist.

The dosage is based on your age, weight, medical condition, and response to treatment.

For boys, use this medication usually 3 times a week or as directed by your doctor. For women, use this medication usually for 1 dose after finishing your menotropins treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark the day(s) on the calendar when you need to receive the medication.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.

Profasi description

Profasi consists of a freeze-dried powder for injection and a solvent for reconstitution. The active ingredient [Profasi] which is obtained from the urine of pregnant women, has luteinizing hormone (LH) activity. The powder is a white, dry powder or cake. The solvent is a clear and colourless aqueous solution.

Each ampoule also contains the following excipients: Mannitol, disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium carboxymethylcellulose. Each ampoule of solvent contains sodium chloride 9 mg and water for injection 1 mL.

Profasi dosage

For Subcutaneous Use Only

Infertile Women Undergoing Assisted Reproductive Technologies (ART)

Profasi® PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent. Profasi® PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. Administration should be withheld in situations where there is an excessive ovarian response, as evidenced by clinically significant ovarian enlargement or excessive estradiol production.

Infertile Women Undergoing Ovulation Induction (OI)

Profasi® PreFilled Syringe should not be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography.

Profasi® PreFilled Syringe 250 µg should be administered one day following the last dose of the follicle stimulating agent.

Profasi® PreFilled Syringe administration should be withheld in situations where there is an excessive ovarian response, as evidenced by multiple follicular development, clinically significant ovarian enlargement or excessive estradiol production.

Directions for Administration of Profasi® Prefilled Syringe

Profasi® PreFilled Syringe is intended for a single subcutaneous injection. Any unused material should be discarded.

Profasi® PreFilled Syringe may be self-administered by the patient. Follow the directions below for injecting Profasi® PreFilled Syringe.

Step 1: Wash your hands thoroughly with soap and water.

Step 2: Carefully clean the injection site.

Make yourself comfortable by sitting or lying down. Carefully clean the injection site on the stomach with an alcohol wipe and allow it to air-dry.

Step 3: Administer your injection.

Carefully remove the needle cap from the syringe. Do not touch the needle or allow the needle to touch any surface. Inject the prescribed dose as directed by your doctor, nurse or pharmacist.

Step 4: Gently withdraw the needle.

Discard the needle and syringe into your safety container. Place gauze over the injection site. If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage.

Step 5: Storage and clean up.

Remember that your injection materials must be kept sterile and cannot be reused.

Profasi interactions

See also:
What other drugs will affect Profasi?

Interactions of Profasi with other medicines have not been investigated; interactions with commonly used medicinal products cannot be excluded.

Following administration, Profasi may interfere for up to 10 days with the immunological determination of serum/urinary Profasi, leading to a false positive pregnancy test.

Incompatibilities: In the absence of compatibility studies, Profasi must not be mixed with other medicinal products.

Profasi side effects

See also:
What are the possible side effects of Profasi?

In comparative trials with different doses of Profasi, the following adverse effects were found to be associated with Profasi in a dose-related fashion: Ovarian hyperstimulation syndrome, vomiting and nausea. Ovarian hyperstimulation syndrome was observed in approximately 4% of patients treated with Profasi. Severe ovarian hyperstimulation syndrome was reported in <0.5% patients.

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 Profasi.

Ectopic pregnancy, ovarian torsion and other complications have been reported in patients after hCG administration. These are considered concomitant effects related to ART.

After best evidence assessment, the following adverse effects may be observed after administration of Profasi.

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 OHSS.

Uncommon (>1/1000, <1/100): Psychiatric Disorders: Depression, irritability, restlessness.

Gastrointestinal System Disorders: Diarrhea.

Reproductive Disorders: Severe OHSS, breast pain.

Profasi contraindications

See also:
What is the most important information I should know about Profasi?

Hypersensitivity to choriogonadotropin α or to any of the excipients of Profasi. Tumors of the hypothalamus and pituitary gland; ovarian enlargement or cyst due to reasons other than polycystic ovarian disease; gynecological hemorrhages of unknown etiology; ovarian, uterine or mammary carcinoma; extrauterine pregnancy in the previous 3 months; active thromboembolic disorders.

Profasi must not be used when an effective response cannot be obtained eg, primary ovarian failure, malformations of sexual organs incompatible with pregnancy, fibroid tumors of the uterus incompatible with pregnancy, postmenopausal women.

Active ingredient matches for Profasi:

Human chorionic gonadotropin in Greece, India, Ireland, Luxembourg, Peru.

Choriogonadotropin alfa

Chorionic Gonadotrophin in Bulgaria.

Hcg in Singapore.

Chorionic gonadotropin

Human chorionic gonadotrophin in India.

References

1. PubChem. "Choriogonadotropin alfa". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
2. PubChem. "HCG". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "Choriogonadotropin alfa - DrugBank". http://www.drugbank.ca/drugs/DB00097 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology