Pregofact H

Uses

Hydroxyprogesterone is a progestin used to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

Pregofact H is also used to associated treatment for these conditions: Abnormal Uterine Bleeding, Premature Births, Primary Amenorrhoea, Secondary Amenorrhea, Stage 3 adenocarcinoma of the uterine corpus, Stage 4 adenocarcinoma of the uterine corpus

How Pregofact H works

The mechanism by which progesterone prevents preterm birth is not well understood, but many pathways are likely involved. (1) Progesterone plays a vital role in regulation of the female reproductive system and is important for successful implantation of the embryo and maintenance of pregnancy. It acts by binding to progesterone receptors in the uterus, ovaries, breasts and in the central nervous system. These receptors exist in 2 isoforms, PR-A and PR-B. Progesterone binding to these receptors ultimately leads to regulation of gene transcription. (2) This results in an anti-inflammatory effect which blunts the proinflammatory state that occurs with initiation of labor, and maintains uterine queiscence by stabilizing progesterone acting on the myometrium. (2)

Dosage

Pregofact H dosage

Hydroxyprogesterone auto-injector: Administer subcutaneously using Hydroxyprogesterone auto-injector at a dose of 275 mg (1.1 mL) once weekly, in the back of either upper arm

Hydroxyprogesterone (single- and multi-dose vials): Administer intramuscularly at a dose of 250 mg (1 mL) once weekly in the upper outer quadrant of the gluteus maximus

Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation

Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first

Side Effects

Most Common: Injection site reactions (pain, swelling, pruritus, nodule), Hives, Itching, nausea, and diarrhea.Call your doctor if you get any of the symptoms bellow:

• Blood clots Symptoms: Leg swelling, Redness in your leg, a spot on your leg that is warm to touch, Leg pain that worsens when you bend your foot.
• Allergic reactions: Hives, Itching, Swelling of the face

Toxicity

Injection site pain is the most common adverse effect associated with hydroxyprogesterone caproate. Other commonly reported adverse effects include: injection site swelling, urticaria, pruritus, injection site pruritus, nausea, injection site nodule, and diarrhea. (4)

Precaution

Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs

Allergic reactions: Consider discontinuing if allergic reactions occur

Decreased glucose tolerance: Monitor prediabetic and diabetic women receiving Makena

Fluid retention: Monitor women with conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction

Depression: Monitor women with a history of clinical depression; discontinue Makena if depression recurs

Interaction

No drug-drug interaction has been reported.

Food Interaction

Volume of Distribution

Hydroxyprogesterone caproate has a high volume of distribution. (3)

Elimination Route

Absorption of 17-hydroxyprogesteron caproate is slow, occurring over a long period of time. (3)

Half Life

Half-life = 16 days (±6 days). (3)

Clearance

Clearance is highly variable from patient to patient. (3)

Elimination Route

Following intramuscular injection, approximately 50% of hydroxyprogesterone caproate metabolites are eliminated in the feces, while approximately 30% of metabolites are eliminated in the urine. (3)

Pregnancy & Breastfeeding use

Pregnancy category B. Low levels of progestins are present in human milk with the use of progestin-containing products, including hydroxyprogesterone caproate. Published studies have reported no adverse effects of progestins on the breastfed child or on milk production.

Contraindication

• Current or history of thrombosis or thromboembolic disorders.
• Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions.
• Undiagnosed abnormal vaginal bleeding unrelated to pregnancy.
• Cholestatic jaundice of pregnancy.
• Liver tumors, benign or malignant, or active liver disease, Uncontrolled hypertension

Special Warning

Pediatric Use: Hydroxyprogesterone is not indicated for use in women under 16 years of age. Safety and effectiveness in patients less than 16 years of age have not been established. A small number of women under age 18 years were studied; safety and efficacy are expected to be the same in women aged 16 years and above as for users 18 years and older

Hepatic Impairment: No studies have been conducted to examine the pharmacokinetics of Hydroxyprogesterone in patients with hepatic impairment. Hydroxyprogesterone is extensively metabolized and hepatic impairment may reduce the elimination of Hydroxyprogesterone .

Acute Overdose

No adverse events associated with over dosage has been reported.

Storage Condition

Store at 20° to 25°C. Do not refrigerate or freeze. Protect auto-injector from light.

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