HYDROXYPROGESTERONE CAPROATE — hydroxyprogesterone caproate injection
AuroMedics Pharma LLC
Hydroxyprogesterone caproate injection is a progestin indicated 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 hydroxyprogesterone caproate injection 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.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
- Hydroxyprogesterone caproate injection (Single-dose vials): Administer intramuscularly at a dose of 250 mg (1 mL) once weekly (every 7 days) in the upper outer quadrant of the gluteus maximus by a healthcare provider
- 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
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Hydroxyprogesterone caproate injection is a clear pale yellow to yellow color oily solution. The solution must be clear at the time of use; replace vial if visible particles or crystals are present.
Specific instructions for administration by dosage form:
Hydroxyprogesterone caproate injection single-dose vials (intramuscular use only) Hydroxyprogesterone caproate injection single-dose vials are only for intramuscular injection with a syringe into the upper outer quadrant of the gluteus maximus, rotating the injection site to the alternate side from the previous week, using the following preparation and administration procedure:
- Clean the vial top with an alcohol swab before use.
- Draw up 1 mL of drug into a 3 mL syringe with an 18 gauge needle.
- Change the needle to a 21 gauge 1½ inch needle.
- After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended.
- Applying pressure to the injection site may minimize bruising and swelling.
Intramuscular injection: 250 mg/mL clear pale yellow to yellow color oily solution in single-dose vials.
Do not use hydroxyprogesterone caproate in women with any of the following conditions:
- 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
Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of hydroxyprogesterone caproate or with other products containing castor oil. Consider discontinuing the drug if such reactions occur.
A decrease in glucose tolerance has been observed in some patients on progestin treatment. The mechanism of this decrease is not known. Carefully monitor prediabetic and diabetic women while they are receiving hydroxyprogesterone caproate.
Because progestational drugs may cause some degree of fluid retention, carefully monitor women with conditions that might be influenced by this effect (e.g., preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction).
Carefully monitor women who develop hypertension while receiving hydroxyprogesterone caproate and consider whether the benefit of use warrants continuation.
For the most serious adverse reactions to the use of progestins, see Warnings and Precautions (5).
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In a vehicle (placebo)-controlled clinical trial of 463 pregnant women at risk for spontaneous preterm delivery based on obstetrical history, 310 received 250 mg of hydroxyprogesterone caproate and 153 received a vehicle formulation containing no drug by a weekly intramuscular injection beginning at 16 to 20 weeks of gestation and continuing until 37 weeks of gestation or delivery, whichever occurred first. [See Clinical Studies (14.1).]
Certain pregnancy-related fetal and maternal complications or events were numerically increased in the hydroxyprogesterone caproate-treated subjects as compared to control subjects, including miscarriage and stillbirth, admission for preterm labor, preeclampsia or gestational hypertension, gestational diabetes, and oligohydramnios (Tables 1 and 2).
|1 N = Total number of subjects enrolled prior to 20 weeks 0 days2 N = Total number of subjects at risk ≥ 20 weeks|
|Pregnancy Complication||Hydroxyprogesterone Caproate n/N||Control n/N|
|Miscarriage (< 20 weeks)1||5/209||0/107|
|Stillbirth (≥ 20 weeks)2||6/305||2/153|
|1 Other than delivery admission.|
|Pregnancy Complication||Hydroxyprogesterone Caproate N=310 %||Control N=153 %|
|Admission for preterm labor1||16.0||13.8|
|Preeclampsia or gestational hypertension||8.8||4.6|
Common Adverse Reactions:
The most common adverse reaction with intramuscular injection was injection site pain, which was reported after at least one injection by 34.8% of the hydroxyprogesterone caproate group and 32.7% of the control group. Table 3 lists adverse reactions that occurred in ≥ 2% of subjects and at a higher rate in the hydroxyprogesterone caproate group than in the control group.
|Preferred Term||Hydroxyprogesterone Caproate N=310 %||Control N=153 %|
|Injection site pain||34.8||32.7|
|Injection site swelling||17.1||7.8|
|Injection site pruritus||5.8||3.3|
|Injection site nodule||4.5||2.0|
In the clinical trial using intramuscular injection, 2.2% of subjects receiving hydroxyprogesterone caproate were reported as discontinuing therapy due to adverse reactions compared to 2.6% of control subjects. The most common adverse reactions that led to discontinuation in both groups were urticaria and injection site pain/swelling (1% each).
Pulmonary embolus in one subject and injection site cellulitis in another subject were reported as serious adverse reactions in hydroxyprogesterone caproate-treated subjects.
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