Patient Assistance Programs for Hydroxyprogesterone Patient assistance programs (PAPs) are usually sponsored by pharmaceutical companies and provide free or discounted medicines to low income or uninsured and under-insured people who meet specific guidelines. Eligibility requirements vary for each program.
Full Answer
What is hydroxyprogesterone used for?
Hydroxyprogesterone is a member of the progestins drug class and is commonly used for Premature Labor. Brand names for hydroxyprogesterone include Makena. Hydroxyprogesterone Prices. This hydroxyprogesterone price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
How much does hydroxyprogesterone cost?
Brand names for hydroxyprogesterone include Makena. This hydroxyprogesterone price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies. The cost for hydroxyprogesterone intramuscular solution (250 mg/mL) is around $419 for a supply of 1 milliliter(s), depending on the pharmacy you visit.
Can enrollment in the Patient Assistance Program be retroactive?
Enrollment into the program cannot be retroactive. † Restrictions apply. Patient must be at or below 500% federal poverty level based on residency to participate in patient assistance program. Contact Makena Care Connection for full program details.
What is the drug class for premature labor?
How much does a free drug card save?
Is hydroxyprogesterone a valid insurance?
About this website
What is the cost of hydroxyprogesterone?
The cost for hydroxyprogesterone intramuscular solution (250 mg/mL) is around $300 for a supply of 1 milliliter(s), depending on the pharmacy you visit....Intramuscular Solution.QuantityPer unitPrice1 milliliter$300.20 – $418.77$300.20 – $418.775 milliliters$307.90 – $922.31$1,539.50 – $4,611.57
What is Makena Care Connection?
Makena Care Connection offers support that helps make filling prescriptions easier, addresses your patients' financial concerns, and helps patients proactively navigate known barriers to therapy.
Is Makena shot covered by insurance?
As a specialty injectable, Makena can be covered by insurance plans as a pharmacy or medical benefit.
How do I order from Makena?
Page 1Makena® Referral/Prescription Form.To ensure enrollment, please fax to the Makena Care Connection® (1-800-847-3413) Telephone 1-800-847-3418 • www.makena.com.STEP 1 — Complete Patient and Insurance Information (Required; please include copies of front and back of insurance cards)
Is Makena still on the market?
Makena remains on the market, pending the decision from the Chief Scientist after a hearing takes place about whether to withdraw Makena's approval.
Does Makena affect baby?
In a clinical study, taking Makena significantly lowered the rate of preterm birth compared to moms who did not take Makena. If you answer “yes” to all of the questions below, talk with your healthcare provider to see if Makena could help you reduce your risk of another preterm birth.
What is the cost of Makena?
When Makena first went on the market six years ago, its price was nearly $1,500 per dose. After complaints of price-gouging, it was reduced to $690 a dose and now costs about $550 a dose.
How long after last Makena did labor start?
Took Makena with the second starting at 16 weeks through 36 weeks. Went into labor about 3 days after stopping the medication.
How do I bill for Makena injections?
To be reimbursed for the Makena injection, the following must be indicated on the claim according to the completion instructions for the 1500 Health Insurance Claim Form: A quantity of 250 mg for a single DOS. Procedure code J1726 (Injection, hydroxyprogesterone caproate, Makena, 10 mg)
How long do you get Makena shots?
Makena is administered once weekly (every 7 days) by your healthcare provider, between 16 and 20 weeks, 6 days, continuing until 37 weeks (your last injection could be as late as 36 weeks, 6 days) or until you deliver your baby, whichever happens first.
Do Makena shots hurt?
The shot is pretty painful at first but after the first few you get used to soreness/ itchiness. But is it worth having a healthy baby? YES.” For Premature Labor: “I had a premature baby at 24 weeks old.
Does the Makena shot make you tired?
Common side effects of Makena include pain, swelling, and itching at the injection site. Makena can also cause dizziness and/or drowsiness. Do not drive or operate heavy machinery until you know how Makena affects you.
Is there a generic for Makena?
American Regent announced the launch of Hydroxyprogesterone Caproate Injection, the first preservative-free, generic version of AMAG's Makena. Hydroxyprogesterone Caproate is used to lower the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Why was Delalutin taken off the market?
In 2000, at the request of the manufacturer Bristol-Myers Squibb, the FDA withdrew approval of Delalutin because the drug had not been marketed for several years. However, hydroxyprogesterone subsequently remained available exclusively through pharmacy compounding with limited regulatory oversight.
Can you give yourself Makena shot?
Do not give yourself MAKENA injections. A healthcare provider will give you the MAKENA injection 1 time each week (every 7 days) either: in the back of your upper arm as an injection under the skin (subcutaneous), or. in the upper outer area of the buttocks as an injection into the muscle (intramuscular).
What are the side effects of the Makena shot?
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
Hydroxyprogesterone Prices, Coupons & Savings Tips - GoodRx
HYDROXYPROGESTERONE is a female hormone. This medicine is used in women who are pregnant and who have delivered a baby too early (preterm) in the past. It helps lower the risk of having a preterm baby again.
Makena Reviews & Ratings - Drugs.com
For Premature Labor: “After two pregnancies that ended in loss at 24 weeks, my doctor did a cerclage at 12 weeks and started me on Makena injection at 16 weeks. I got it in the hip and if it is done right and injected slowly, the pain is not as bad as when it isn't. I seriously cried on some of those because the pain was so bad.
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Makena Prices, Coupons & Savings Tips - GoodRx
Compare prices, print coupons and get savings tips for Makena (Hydroxyprogesterone) and other Preterm Labor drugs at CVS, Walgreens, and other pharmacies.
How do I apply for the Makena patient assistance program?from nicerx.com
Our application process aims to make it as easy as possible to apply for the Makena patient assistance program. The first step is to complete our online enrollment application. We will ask you for details about your healthcare provider, your insurance plan, and your household income as this information is required by the pharmaceutical companies. We may be able to help you apply for other patient assistance programs too, so be sure to tell us about any medications you are taking as well as Makena.
How much does a free drug card save?from drugs.com
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
Is NiceRx a Makena coupons provider?from nicerx.com
When obtaining your medication through NiceRx, you will only pay $49 a month per medication. This will likely save you more money than if you were to use Makena coupons, discount cards, or Makena copay cards.
Can Prescription Hope help me with Makena if I have prescription medication coverage?
Prescription Hope works alongside many prescription medication coverage plans and fill the coverage gap individuals may fall into through insurance and Medicare. Through our unique pharmacy program, Prescription Hope can obtain prescription medications without copays, deductibles or medication tiers.
Can I obtain other prescription medications through Prescription Hope?
In addition to Makena, Prescription Hope can obtain over 1,500 FDA-approved prescription medications. There is no limit to the number of medications individuals can receive through our pharmacy program.
Is Prescription Hope an insurance policy or discount drug card?
Prescription Hope is the only national program that works directly with over 180 U.S. based pharmaceutical manufacturers and their pharmacy to obtain prescription medications at an affordable price. Through our revolutionary pharmacy program that bridges the gap between medicine and individuals, our team can obtain over 1,500 FDA-approved prescription medications, including the top 100 prescribed medications in the United States.
What is accelerated approval?
Accelerated approval is intended to speed the availability of drugs that treat serious or life-threatening diseases or conditions and that may provide a meaningful advantage over available therapies. For accelerated approval, the applicant still must provide substantial evidence based on adequate and well-controlled clinical investigations that the benefits of the drug outweigh its risks, but the effect is shown on a surrogate endpoint that is reasonably likely (not known) to predict benefit in how patients feel, function, or survive. For Makena’s approval, the surrogate endpoint was reducing the risk of preterm birth (birth before 37 weeks); a surrogate endpoint that CDER determined was reasonably likely to predict clinical benefit to the newborn. Compared to traditional approval, there is uncertainty at the time of accelerated approval whether the drug will ultimately be shown to provide clinical benefit to patients. Therefore, drugs approved under accelerated approval must undergo confirmatory clinical trial (s) after approval to verify that the drug improves how patients feel, function, or survive and to describe the extent of such improvement. The FDA may withdraw approval of a drug granted accelerated approval if the confirmatory trial (s) fail to verify clinical benefit.
What is the requirement for approval of a drug?
For traditional (regular) approval of a drug, there must be substantial evidence of effectiveness, and the benefits of the drug must outweigh the risks. To establish effectiveness, the drug generally must be shown to have a direct benefit on how a patient feels, functions or survives (clinical benefit).
What happens if AMAG does not agree to voluntary withdrawal?
If AMAG does not agree to voluntary withdrawal, it may request a public hearing. The application holders of the generics of Makena can submit written comments on CDER’s proposal to withdraw approval of Makena and its generic equivalents.
What is the term for delivery before 37 weeks?
Preterm birth refers to delivery before 37 weeks of pregnancy. The goal of reducing preterm birth is to improve health outcomes of the baby (the clinical benefit), as premature babies can have significant health problems.
What is a surrogate endpoint?
A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, or other measure that does not directly measure benefit to the patient.
Can HPC be compounded?
A. HPC cannot be compounded for the specific indication “to reduce the risk of recurrent preterm birth” if Makena is withdrawn from the market and HPC is placed on the withdrawn or removed list for this indication.
How to report adverse events to AMAG?from makena.com
You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing [email protected]. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information for Makena.
Is Makena a progestin?from makena.com
Makena 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 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.
How to report adverse events to AMAG?from makena.com
You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing [email protected]. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information for Makena.
How much does a free drug card save?from drugs.com
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
How to contact Makena Copay Assistance?
Form more information phone: 800-847-3418 or Visit website. Makena Copay Assistance Program: Eligible uninsured/underinsured patients may receive a free course of therapy; for additional information contact the program at 800-847-3418.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
How long does singleton medication last?from drugs.com
To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth:#N#16 years and older:#N#250 mg intramuscularly once weekly.#N#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.
How to know if you have a syringe?from drugs.com
Call your doctor at once if you have: 1 swelling, oozing, bleeding, or worsening pain where the injection was given; 2 jaundice (yellowing of the skin or eyes); 3 symptoms of depression (sleep problems, weakness, mood changes); 4 swelling in your hands, ankles, or feet; 5 increased blood pressure - severe headache, blurred vision, pounding in your neck or ears, anxiety, nosebleed; or 6 signs of a blood clot - sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.
Does hydroxyprogesterone caproate increase CYP1A2?from drugs.com
Drug Interactions. Cytochrome P450 (CYP) enzymes: An in vitro inhibition study using human liver microsomes and CYP isoform-selective substrates indicated that hydroxyprogesterone caproate increased the metabolic rate of CYP1A2, CYP2A6, and CYP2B6 by approximately 80%, 150%, and 80%, respectively.
Is hydroxyprogesterone a synthetic progesterone?from drugs.com
Hydroxyprogesterone caproate is a synthetic progestin. The mechanism by which hydroxyprogesterone caproate reduces the risk of recurrent preterm birth is not known.
Does hydroxyprogesterone inhibit CYP2C8?from drugs.com
In vitro data indicated that therapeutic concentration of hydroxyprogesterone caproate is not likely to inhibit the activity of CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 [See Clinical Pharmacology ( 12.3 ).] No in vivo drug-drug interaction studies were conducted with Makena.
Does Makena stop premature labor?from drugs.com
Makena will not stop premature labor that has already begun. Makena is not for use in women who are pregnant with more than one baby (twins, triplets, etc). Hydroxyprogesterone may also be used for purposes not listed in this medication guide.
Can you take Makena if you have high blood pressure?from drugs.com
You should not use Makena if you have: uncontrolled high blood pressure, unusual vaginal bleeding, liver disease or liver cancer, jaundice caused by your pregnancy, or if you have ever had circulation problems, a stroke or blood clot, or cancer of the breast, uterus/cervix, or vagina.
How much does a free drug card save?from drugs.com
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
How much does epinephrine cost?from drugs.com
The cost for epinephrine injectable kit 0.3 mg is around $272 for a supply of 2 kits, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.
How much does Adrenaclick cost at CVS?from drugs.com
Adrenaclick Available at CVS: Eligible cash-paying patients can purchase the authorized generic for Adrenaclick at a cash price of $109.99 for a two-pack; save an additional $10 when you use the savings coupon from drug manufacturer (https://sservices.trialcard.com/Coupon/Epinephrine)
What is the drug class for premature labor?
Hydroxyprogesterone is a member of the progestins drug class and is commonly used for Premature Labor.
How much does a free drug card save?
The free Drugs.com Discount Card works like a coupon and can save you up to 80% or more off the cost of prescription medicines, over-the-counter drugs and pet prescriptions.
Is hydroxyprogesterone a valid insurance?
Prices are for cash paying customers only and are not valid with insurance plans. This hydroxyprogesterone price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.
