Ovidrel

Drug overview for OVIDREL (hcg alpha,recombinant):

Generic name: HCG ALPHA,RECOMBINANT (KOR-ee-o-goe-nad-oh-troe-pin AL-fa)
Drug class: Human Chorionic Gonadotropin (hCG)
Therapeutic class: Endocrine

Choriogonadotropin alfa, a biosynthetic (recombinant DNA-derived) form of human chorionic gonadotropin (hCG), is a gonad-stimulating polypeptide hormone.

Choriogonadotropin alfa is used as a component of infertility regimens (e.g., consisting of a gonadotropin-releasing hormone agonist and follicle-stimulating hormone (FSH)) to induce final follicular maturation and early luteinization in ovulatory women undergoing controlled ovarian hyperstimulation during assisted reproductive technology (ART) programs such as in vitro fertilization and embryo transfer. The drug also is used in conjunction with follicle-stimulating hormones to induce ovulation and pregnancy in anovulatory, infertile women in whom the cause of anovulation is functional (i.e., secondary to pituitary insufficiency) and not due to primary ovarian failure.

DRUG IMAGES

OVIDREL 250 MCG/0.5 ML SYRG

The following indications for OVIDREL (hcg alpha,recombinant) have been approved by the FDA:

Indications:
Follicle stimulation for assisted fertilization procedure
Ovarian follicle maturation induction

Professional Synonyms:
Multifollicular development for assisted reproductive technologies

Dosing information for OVIDREL
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
OVIDREL 250 MCG/0.5 ML SYRG	Maintenance	Adults inject 0.5 milliliter (250 mcg) by subcutaneous route once daily for 1 day

The following contraindication information is available for OVIDREL (hcg alpha,recombinant):

Overview
Contraindicated
Severe
Moderate

Drug contraindication overview.

Known hypersensitivity to human chorionic gonadotropin preparations (including urinary-derived HCG) or any ingredient in the formulations. Primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; uncontrolled organic intracranial lesions such as pituitary tumors; abnormal uterine bleeding of undetermined origin; ovarian cysts or enlargement of undetermined origin; sex-hormone dependent tumors of the reproductive tract and accessory organs; and pregnancy.

There are 8 contraindications. Absolute contraindication.

Contraindication List
Abnormal uterine bleeding
Carcinoma of breast
Malignant neoplasm of the ovary
Malignant neoplasm of the uterus
Ovarian cyst
Pituitary neoplasm
Pregnancy
Primary ovarian failure

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Ovarian hyperstimulation
Thromboembolic disorder

There are 0 moderate contraindications.

The following adverse reaction information is available for OVIDREL (hcg alpha,recombinant):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects occurring in 2% or more of patients receiving choriogonadotropin alfa include injection site disorders (i.e., pain, bruising), abdominal pain, nausea, vomiting, or postoperative pain occurred during ART programs. Injection site disorders (i.e., pain, inflammation, bruising, injection site reaction), ovarian cysts, ovarian hyperstimulation, or abdominal pain occurred during ovulation induction treatment.

There are 4 severe adverse reactions.

More Frequent	Less Frequent
None.	Ovarian cyst Ovarian hyperstimulation syndrome

Rare/Very Rare
Anaphylaxis Thromboembolic disorder

There are 5 less severe adverse reactions.

More Frequent	Less Frequent
Injection site sequelae	Abdominal pain with cramps Nausea Vomiting

Rare/Very Rare
Skin rash

The following precautions are available for OVIDREL (hcg alpha,recombinant):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy not established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category X. (See Users Guide.)

Not known whether choriogonadotropin alfa is distributed in milk. Caution is advised if the drug is administered in nursing women.

Safety and efficacy not established.

Follicle stimulation for assisted fertilization
Z31.83	Encounter for assisted reproductive fertility procedure cycle
Z31.89	Encounter for other procreative management
Z52.81	Egg (oocyte) donor
Z52.810	Egg (oocyte) donor under age 35, anonymous recipient
Z52.811	Egg (oocyte) donor under age 35, designated recipient
Z52.812	Egg (oocyte) donor age 35 and over, anonymous recipient
Z52.813	Egg (oocyte) donor age 35 and over, designated recipient
Z52.819	Egg (oocyte) donor, unspecified
Ovarian follicle maturation induction
Z31.83	Encounter for assisted reproductive fertility procedure cycle
Z31.89	Encounter for other procreative management