hydroxyprogesterone caproate

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hydroxyprogesterone caproate

(hye-drox-ee-pro-jess-te-rone kap-roe-ate) ,

Makena

(trade name)

Classification

Therapeutic: hormones
Pharmacologic: progestins
Pregnancy Category: B

Indications

To ↓ the risk of preterm birth in women with a singleton pregnancy who have a history of previous singleton preterm birth.

Action

A synthetic analog of progesterone. Produces secretory changes in the endometrium. ↑s basal temperature. Produces changes in the vaginal epithelium. Relaxes uterine smooth muscle. Stimulates mammary alveolar growth. Inhibits pituitary function.
Action in reducing risk of recurrent preterm birth is unknown.

Therapeutic effects

↓ risk of preterm birth in women at risk.

Pharmacokinetics

Absorption: Slowly absorbed following IM administration.
Distribution: Unknown.
Protein Binding: Extensively bound to plasma proteins.
Metabolism and Excretion: Extensively metabolized by the liver.
Half-life: 7.8 days.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
IMunknown4.6 days7 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity to hydroxyprogesterone or castor oil;History of or known thrombosis/thromboembolic disorder;History of or known/suspected breast cancer or other hormone-sensitive cancer;Unexplained abnormal vaginal bleeding unrelated to pregnancy;Cholestatic jaundice of pregnancy;Benign/malignant liver tumors or active liver disease;Uncontrolled hypertension.
Use Cautiously in: Risk factors for thromboembolic disorders (may ↑ risk);Diabetes mellitus or risk factors for diabetes mellitus (may impair glucose tolerance);History of preeclampsia, epilepsy, cardiac or renal impairment (may be adversely affected by fluid retention);History of depression (may worsen);Safe and effective use in children <16 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • depression

Cardiovascular

  • hypertension

Gastrointestinal

  • diarrhea
  • jaundice
  • nausea

Dermatologic

  • urticaria (most frequent)
  • pruritus

Fluid and Electrolyte

  • fluid retention

Hematologic

  • thromboembolism (life-threatening)

Local

  • injections site reactions (most frequent)

Miscellaneous

  • allergic reactions including angioedema

Interactions

Drug-Drug interaction

May ↑ metabolism and ↓ blood levels and effectiveness of drugs metabolized by the CYP1A2, CYP2A6 and CYP2B6 enzyme systems.

Route/Dosage

Intramuscular (Adults) 250 mg once weekly starting between 16 wks, 0 days and 20 wks, 6 days continuing until wk 37 of gestation or delivery, whichever occurs first.

Availability

Solution for IM injection (contains castor oil): 1250 mg/5 mL vial (250 mg/mL)

Nursing implications

Nursing assessment

  • Monitor for signs and symptoms of thromboembolic disorders throughout therapy.
  • Monitor vital signs during therapy. If hypertension occurs, consider discontinuation of therapy.
  • Assess for signs and symptoms of allergic reactions (urticaria, pruritus, angioedema) during therapy. Consider discontinuation if allergic reactions occur.
  • Monitor for fluid retention during therapy, especially in patients at ↑ risk for complications (preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction).
  • Assess mental status and mood changes, especially in women with a history of depression. Discontinue hydroxyprogesterone if depression recurs or worsens.
  • Lab Test Considerations: May ↓ glucose tolerance. Monitor serum glucose in prediabetic and diabetic women during therapy.

Potential Nursing Diagnoses

Deficient knowledge, related to disease process and medication regimen (Patient/Family Teaching)

Implementation

  • Intramuscular: Draw up 1 mL of solution into a 3 mL syringe with an 18 gauge needle. Solution is clear, yellow, viscous and oily. Do not administer solutions that are cloudy or contain particles. Change needle to 21 gauge 1 1/2 inch needle. Inject into upper outer quadrant of gluteus maximus slowly, over 1 min or longer. Apply pressure to injection site to minimize bruising and swelling. Store hydroxyprogesterone in original box, at room temperature, protected from light. Discard unused product after 5 wks from first use.

Patient/Family Teaching

  • Instruct patient to continue to receive injection weekly from health care professional. If a dose is missed, consult health care professional for instructions regarding returning to schedule.
  • Advise patient to notify health care professional if signs and symptoms of blood clots (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), depression, or yellowing of skin and whites of the eyes occur.
  • Inform patient that injection site reactions (pain, swelling, itching, bruising, nodule formation) may occur. If ↑ pain over time, oozing of blood or fluid, or swelling occur, notify health care professional.

Evaluation/Desired Outcomes

  • ↓ risk of preterm birth in women at risk.
References in periodicals archive ?
When monopolistic corporations control the internet, they control our ability to speak out against them and organize a resistance, said Ing (Kihei, Wailea, Makena).
M2 PHARMA-October 14, 2016-AMAG Pharmaceuticals achieves two key milestones in Makena and Feraheme development programs
The company markets the US Food and Drug Administration (FDA)-approved Makena product, which aims to reduce the risk of pre-term birth.
of Exeter, N.H., Catherine Keith of Amesbury, Mary Alex of Bolton and Clare Ouellette of Auburn; his siblings, William McCarty, Elizabeth Reggio, Ruth Doonan, Barbara McMichael and Robert Smith; grandchildren, Camlyn Ross, Lauren Emerson, Rory Alex, Kristy Grignon, Dustin Laferriere, Nathaniel, Zachary and Jamison Bibaud; great-grandchildren, Colby and Zachary Emerson, Madison Grignon, Kalia and Makena Ross, Andrew and Olivia Alex, numerous nieces, nephews, cousins, and many friends.
The shark attack occurred at the Makena Landing Beach Park on Maui, reports (http://www.mauinews.com/page/content.detail/id/566411.html) Maui News .
The Food and Drug Administration approved Makena (a noncompounded form of 17P) earlier this year for the prevention of recurrent preterm birth in women "with singleton pregnancies.
LOUIS -- The Food and Drug Administration has granted approval of K-V Pharmaceutical Co.'s Makena (hydroxyprogesterone caproate injection), the first FDA-cleared treatment to reduce the risk of preterm birth in women with a singleton pregnancy (one baby) who have a history of singleton spontaneous preterm birth.
MISAMON and Makena made it a day that trainer Dai Rees and conditional jockey John Mathias will not forget when providing the pair with their first doubles under rules, at odds of 98-1, writes Tony Elves.
WORCESTER: 2.10 Makena, 2.40 Lukie Victor, 3.10 Apartman, 3.40 Alhaque, 4.10 The Iron Giant, 4.40 Misamon, 5.10 Supreme Plan, 5.40 Arumun.
High school awards went to Zack Lehman, first place; Sam Dale, second place; Makena Starner, third place; and Mary Biwersi, Katie Calef, Shelby Lynn Harvey, Kelleen Richins and Shanda Zettle, honorable mentions.
Only two went to post for the members' race and the long odds on Makena, partnered by Alan Johns, 19, finished alone after Mr Who unseated Ruth Birt-Llewellin at the ninth fence.
They are repeat players to the island." While Wailea is hot -- Cella sold four oceanfront lots there this summer for around $5 million per lot -- Makena is building, lending itself to larger estates and more privacy.