Choriogonadotropin Alfa

Choriogonadotropin Alfa may be found in some form under the following brand names:

• A.p.l.

• Chorex

• Chorigon

• Gonic

• Novarel

• Ovidrel

• Pregnyl

• Profasi

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• follicle stimulating hormone
• ganirelix

This is not a complete list of Choriogonadotropin Alfa drug interactions. Ask your doctor or pharmacist for more information.

Use Choriogonadotropin Alfa exactly as prescribed.

Choriogonadotropin Alfa is available in an injectable form to be given directly into a muscle by a healthcare professional. It is typically given three to four times per week when used to promote descent of the testicles, two to three times per week when used to boost hormone levels in men, and as one dose per treatment when used to promote pregnancy in women.

Choriogonadotropin Alfa has not been demonstrated to increase weight loss or otherwise treat obesity.

• Store at 20° to 25°C (68° to 77°F)
• Keep this and all medicines out of the reach of children

Female Infertility

Used in conjunction with other infertility agents (e.g., gonadotropin-releasing hormone agonist, FSH) for induction of final follicular maturation and early luteinization in ovulatory, infertile women during assisted reproductive technology (ART) programs.1 2 3 6 7 8 9

Use in patients with tubal obstruction only if participating in ART programs.1

Choriogonadotropin alfa (r-hCG) is equivalent to urinary-derived hCG with regard to number of oocytes recovered, fertilized oocytes or embryos, and live births.1 2 3

Used in conjunction with follicle-stimulating agent to induce ovulation in anovulatory, infertile women in whom anovulation is functional and not due to primary ovarian failure.1 4 5 h

Choriogonadotropin alfa (r-hCG) is similar to urinary-derived hCG with regard to ovulation rates.1 h

Absorption

Bioavailability

Following sub-Q administration, absolute bioavailability is 40%.1 b Peak serum concentrations attained in 12–24 hours; detectable in serum for 10 days.1 d e h

Onset

Following midcycle administration, peak stimulation of luteal-phase progesterone production (as indicated by serum progesterone concentrations) occurs in approximately 5–7 days.e h (See Actions.)

Duration

Following midcycle administration, stimulation of luteal-phase progesterone production persists for approximately 10 days.e h

Distribution

Extent

Median apparent volume of distribution is 21.4 L in women undergoing in vitro fertilization.1

Elimination

Metabolism

Urinary-derived hCG extensively metabolized, principally in the liver and kidneys, to active metabolites; urinary-derived choriogonadotropin alfa (r-hCG) exhibits similar pharmacokinetics as hCG.a k

Elimination Route

Excreted in urine principally as metabolites.a

Half-life

Biphasic; median terminal half-life is 29.2 hours in women undergoing in vitro fertilization.1

Special Populations

Pharmacokinetics not evaluated in patients with renal or hepatic impairment.1

• A recombinant DNA-derived form of hCG prepared from genetically modified mammalian (Chinese hamster ovary) cells.1 2

• An analog of LH; has physicochemical, immunologic, and biologic activities comparable to those of urinary-derived hCG.1 2

• Substitutes for the endogenous LH surge responsible for ovulation and stimulates late maturation of the ovarian follicle, resumption of oocytic meiosis, and initiation of rupture of the preovulatory ovarian follicle.1 2 3 f Spontaneous midcycle LH surges are inconsistent during controlled ovarian stimulation.g

• Induces and maintains corpus luteum (as evidenced by increased serum progesterone concentrations).1 2 3 e f

• Importance of informing patient of potential adverse effects (e.g., OHSS, multiple gestation).1 c

• Importance of discussing duration of treatment and required monitoring procedures.1

• Importance of patients informing clinician if severe pain or bloating in abdominal or pelvic area, severe upset stomach, vomiting, or weight gain occurs.c

• Importance of patient informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.c

• Importance of women informing their clinician if they plan to breast-feed.c

• Importance of informing patient of other important precautionary information.1 (See Cautions.)

Applies to chorionic gonadotropin (hcg): injectable powder for injection, intramuscular powder for injection, subcutaneous powder for injection, subcutaneous solution

General

General side effects have included headache, irritability, restlessness, fatigue, and edema.[Ref]

Genitourinary

Genitourinary side effects have included precocious puberty and gynecomastia.[Ref]

Psychiatric

Psychiatric side effects have included depression.[Ref]

Local

Local side effects have included pain at the site of injection.[Ref]

Hypersensitivity

Hypersensitivity side effects have included isolated cases of allergic reactions, manifesting mainly as mild reversible skin rashes. Postmarketing reports have included anaphylactic reactions.[Ref]

Hematologic

Hematologic side effects have included the occurrence of arterial thromboembolism.

Some side effects of chorionic gonadotropin (hcg) may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.