hydroxyprogesterone caproate (Rx)

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Brand and Other Names:Makena

Dosing & Uses

AdultPediatric

Dosing Form & Strengths

solution for IM injection

  • 5mL multidose vial: 250mg/mL in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v)
  • 1mL single-dose vial: 250mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v)

Preterm Labor

Indicated for prevention of preterm labor in a singleton pregnancy for patients aged 16 years or older who have a history of spontaneous preterm birth

250 mg IM qWeek

Initiate between the 16th and 20th week of gestation and ending at the 37th week of gestation or birth (whichever is first)

Renal Impairment

Not studied in patients with renal impairment

Hepatic Impairment

Not studied; product is extensively metabolized in liver; potential for reduce elimination

Safety and efficacy not established

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Interactions

Interaction Checker

and hydroxyprogesterone caproate

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site pain (34.8%)

            Injection site swelling (17.1%)

            Urticaria (12.3%)

            1-10%

            Pruritus (7.7%)

            Injection site pruritus (5.8%)

            Nausea (5.8%)

            Injection site nodule (4.5%)

            Diarrhea (2.3%)

            Frequency Not Defined

            Thromboembolic events

            Angioedema

            Depression

            Decreased glucose tolerance

            Fluid retention

            Jaundice

            Hypertension

            Vaginal bleeding

            Postmarketing Reports

            Body as a whole: Local injection site reactions (including erythema, urticaria, rash, irritation, hypersensitivity, warmth); fatigue; fever; hot flashes/flushes

            Digestive disorders: Vomiting

            Infections: Urinary tract infection

            Nervous system disorders: Headache, dizziness

            Pregnancy, puerperium and perinatal conditions: Cervical incompetence, premature rupture of membranes

            Reproductive system and breast disorders: Cervical dilation, shortened cervix

            Respiratory disorders: Dyspnea, chest discomfort

            Skin: Rash

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            Warnings

            Contraindications

            Thromboembolism or history of thromboembolism

            Breast cancer or history of breast cancer

            Hormone sensitive cancer or history of hormone sensitive cancer

            Undiagnosed abnormal vaginal bleeding unrelated to pregnancy

            Liver tumors or active liver disease

            Uncontrolled hypertension

            Hypersensitivity to castor oil or hydroxyprogesterone caproate

            Cautions

            Not intended for use in women with multiple gestations or other risk factors for preterm birth

            Discontinue use if an arterial or deep venous thrombotic or thromboembolic event occurs

            Consider discontinuing if allergic reaction develops Monitor for the development of prediabetes, diabetes, or worsening diabetes

            Carefully monitor patients that have conditions sensitive to fluid retention (eg, preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction)

            Monitor women with history of depression and discontinue if depression recurs

            Carefully monitor women who develop jaundice and consider the risks and benefits of continuation

            Carefully monitor women who develop hypertension and consider the risks and benefits of continuation

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            Pregnancy & Lactation

            Pregnancy Category: B

            No adequate or well-controlled studies in women during first trimester

            Data from controlled studies of 310 women who received hydroxyprogesterone during in their second and third trimesters show no increase in congenital anomalies, including genital abnormalities in male or female infants, from exposure during pregnancy to hydroxyprogesterone caproate

            Lactation: Excreted into breast milk, avoid

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Synthetic progestin

            Mechanism in risk reduction of preterm labor is unknown.

            Absorption

            Note: Pharmacokinetic data based on single 1000 mg IM injection; data for 250 mg dose has not been evaluated

            Peak Plasma Concentration: 3-7 days (after a single IM injection)  

            Peak Plasma Time: 4.6 (± 1.7) days

            Distribution

            Protein Bound: binds extensively to plasma proteins (including albumin and corticosteroid binding globulins

            Metabolism

            Half-Life: 7.8 (± 3.0) days

            Metabolism: hepatic (primarily CYP3A4 and CYP3A5)

            Elimination

            Excretion: feces (50%), urine (30%); both conjugated and free drug  

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            Administration

            IM Administration

            Inject IM over 1 minute in upper outer quadrant of the gluteus maximus

            Inject IM over 1 minute in upper outer quadrant of the gluteus maximus The solution if viscous and oilyThe solution if viscous and oily

            1-mL vial does not contain preservatives and is for single dose use

            Once opened, the 5-mL multidose vial must be used within 5 weeks

            Discard any unused drug remaining in the opened vial after 5 weeks

            Storage

            Store at controlled room temperature 15-30°C (59-86°F)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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