How is makena administered


You can win a beautiful home you've been dreaming or win millions of cash. 17 to 124. Notice: Please be sure to complete this form in its entirety. Learn more about Makena: What it is, if it's right for you, the administration options, and what the possible side effects are. Yes No Is the patient allergic to any ingredients in Makena (hydroxyprogesterone, castor oil, benzyl benzoate or benzyl alcohol)? Yes No Is the prescribed dose up to 275 mg administered weekly via subcutaneous injections or 250 mg Makena, that qualify as covered outpatient drugs under the Medicaid drug rebate program. • Makena is currently available as a 5 mL multidose vial (250 mg/mL) containing 1,250 mg of hydroxyprogesterone caproate. This medication is injected into muscle tissue. Learn more about Medicare prescription drug plans and savings with GoodRx. UnitedHealthcare has developed Medical Policies, Medical Benefit Drug Policies, and Coverage Determination Guidelines to …For participating Amerigroup health care providers or those interested in joining our provider network. Members may not self-administer Makena injections. Hereafter, it will be referred to as 17P. Makena auto-injector: Administer subcutaneously using auto-injector at a dose of 275 mg (1. comExpert Financial Analysis and Reporting. Antares and AMAG Pharmaceuticals are jointly developing a new subcutaneous formulation of AMAG’s key drug Makena which is currently administered as a deep and painful intra-muscular injection. ” —Katie, mom of a 34-week preemie A total of 463 pregnant women were randomized to receive either Makena (N=310) or vehicle (N=153) at a dose of 250 mg administered weekly by intramuscular injection starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation, and continuing until 37 weeks of gestation or delivery. Makena is Makena (hydroxyprogesterone caproate) is a prescription hormone medicine used in women who are pregnant with only one baby and who have delivered a premature baby in the past. In-network providers must obtain authorization 48 …Medical Benefit Applies Prior Authorization for Medical Benefit Drugs. administered drugs are considered a medical benefit in Medi-Cal FFS, Makena is one of the few exceptions where Medi-Cal FFS makes the drug available as a pharmacy benefit as well as a medical benefit. 1 mL) once weekly (every 7 days) in the back of either upper arm by The women were randomized to receive either Makena or vehicle at a dose of 250 mg administered weekly by intramuscular injection starting between 16 Makena is a progestin indicated to reduce the risk of preterm birth in . Don't miss this once in a lifetime chance!Terminology disclaimer The terminology used to describe people with disabilities has changed over time. Indicate where the drug is being administered: Ambulatory surgical Home Inpatient hospital Office Outpatient treatment center Pharmacy 2. Makena is used in these women to help lower the risk of having a preterm baby again. Welcome to November 2018! As the year comes to an end, this season calls for planning and preparation for the upcoming year. Medicare coverage and pricing details for Makena. Revised 10/31/2016 GEORGIA MEDICAID FEE-FOR-SERVICE MAKENA PA SUMMARY STATUS: Preferred LENGTH OF AUTHORIZATION: Up to 21 weeks NOTES: If medication is being administered in a physician’s office, then it must be The FDA found that compounded versions of KV Pharmaceutical's Makena drug for premature babies had few potency or purity issues, raising questions about KV's ability to boost Makena sales and its MakenaTM should be administered intramuscularly by a healthcare professional. The generic name of Makena is hydroxyprogesterone caproate. Makena HMSA – 2/2018. • The recommended dose of Makena is 250 mg (1 mL) administered intramuscularly once weekly. Note: Must be administered in a non-hospital setting. We offer more opportunities for you to win. 07262018 Texas Standard Prior Authorization Form Addendum Molina Healthcare of Texas Makena (Medicaid) This fax machine is located in a secure location as required by HIPAA Regulations. 1 mL) once weekly (every 7 days) in the back of either upper arm by Detailed dosage guidelines and administration information for Makena (hydroxyprogesterone caproate). The Minnesota Department of Human Services (“Department”) supports the …In total over the decades, more than 8500 men, women and children living throughout the Hawaiian islands and diagnosed with leprosy were exiled to the colony …Cathay Post 384 is a veterans organization since 1931 that offers destination dream home raffles. Will Makena be administered weekly from weeks 16 to 36 of gestation? ☐ Yes ☐ No Note: If a member has transferred to UniCare after 16 weeks’ estimated gestational age (EGA) or late Notably, Makena administered subcutaneously via the auto-injector demonstrated bioequivalence for area under the curve (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL for the IM injection), a key Makena® (hydroxyprogesterone caproate) Injectable Medication Precertification Request Aetna Precertification Notification 503 Sunport Lane, Orlando, FL 32809. Makena administered intramuscularly, at gestational exposures up to 5 times the recommended human dose, had no adverse effects on the parental (F 0) dams, their developing offspring (F 1), or the latter offspring's ability to produce a viable, normal second (F 2) generation. Codes:In total over the decades, more than 8500 men, women and children living throughout the Hawaiian islands and diagnosed with leprosy were exiled to the colony …Cathay Post 384 is a veterans organization since 1931 that offers destination dream home raffles. “In 2017, we delivered strong top- and bottom-line results while investing aggressively in the products that we expect will drive future growth and shareholder value,” said Ted Myles, executive vice president and chief financial officer. Makena can either be administered: In the healthcare provider’s office, or; At home during a home healthcare visit (if covered by the patient’s insurance) Makena auto-injector: Administer subcutaneously using Makena auto-injector at a dose of 275 mg (1. We finished 2017 at 1. A progestin for intramuscular administration; may be given subcuatneously using an auto- Intramuscular dosage (single and multi-dose vials Makena only). 1 ) Makena™, 17-alpha hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and hydroxy progesterone. Makena is a provider-administered drug and must be injected by a medical professional. See site of service prior authorization criteria for coverage criteria in a hospital outpatient setting and exceptions for new starts. CVS Caremark Specialty Programs 2969 Mapunapuna Place Honolulu, HI 96819 Phone Indicate where the drug is being administered: Makena dosage is dependent on the individual that it is being administered to. Please read the terms and conditions below carefully. how is makena administeredRead more about the dosing and administration schedule for Makena. This drug must be medically indicated and this must be documented in the chart: A Magnolia Health Plan Notification of Pregnancy Form must be submit- BlueCare . Prior authorization requests must indicate the total number of doses to be R eport Overview. Makena is a once weekly treatment administered by aMakena (hydroxyprogesterone caproate) is a non-preferred product and will only be considered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. The Minnesota Department of Human Services (“Department”) supports the …Hydroxyprogesterone caproate injection (MAKENA) is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have …R eport Overview. Because Makena auto-injector is preservative-free, once the cap is removed the device should be § QuickShot®device used to develop a once-weekly subcutaneous injection of Makena® • Originally administered IM with a large-gauge needle from a single dose vial Following the FDA approval of Makena subcutaneous February 14, the company is set to attain profitability in 2018. . Makena is used to lower the risk of premature birth in a woman who has already had one premature baby. The sub-Q device is also virtually painless to administer (e. Diabetes Medications PA Criteria for oral diabetic medications: To qualify for a tier 2 medication, the member must have a trial of a tier 1 medication (must include a trial of metformin titrated up to maximum dose), or a clinical reason why a tier 1 medication is not appropriate. Follow your medical professional"s directions for best results. Before approving the prescription, Makena Customer Service representatives will need to talk with the woman to ask her a few questions. Open Season starts this month, which is a …List of HCPCS J Codes. HCPCScodes. Our market share continues to grow as well. Dosing and administration process for Makena. Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women Makena™, 17-alpha hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and hydroxy progesterone. org. how is makena administered Two progesterone dosage forms are used to reduce pre-term labor––natural progesterone administered vaginally, and 17-alpha hydroxyprogesterone caproate (17P), a synthetic pro-gestin, administered via the intramuscular (IM) route. Makena is used to lower the risk of premature birth in a woman who has already had one premature baby. Attention All Providers: Requirements on When to Use the National Provider Identifier (NPI) of an Ordering, Prescribing or Referring (OPR) Provider on Claims [Announcement 850]Procedures, programs and drugs you must precertify Participating provider precertification list Starting November 1, 2018 Applies to 1,2,3,4,9Justification for Mode of Transport. Find patient medical information for Makena Intramuscular on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user Makena (hydroxyprogesterone) is used to lower the risk of premature birth in women Continue administration once weekly until week 37 (through 36 weeks, Makena auto-injector: Administer subcutaneously using auto-injector at a dose of 275 mg (1. Subcutaneous: 0. To obtain Prior Authorization for provider-administered specialty drugs (as noted below), your network physician must do one of the following: Hydroxyprogesterone caproate injection is a man-made hormone of progestin. 17P/Makena PA Form to an in-network pharmacy with compounding capability. 17 Alpha-hydroxyprogesterone caproate (17P) 17P is administered through weekly Makena is the only FDA-approved 17P drug currently on the market and was We require prior authorization for compounded 17P and Makena whether administered in the office or by a home health service. Makena is a once weekly treatment administered by aIn total over the decades, more than 8500 men, women and children living throughout the Hawaiian islands and diagnosed with leprosy were exiled to the colony …Cathay Post 384 is a veterans organization since 1931 that offers destination dream home raffles. Also, Makena is administered between weeks 16-20 through week 37 of pregnancy, a relatively short time in the big picture. After receiving a CRL for its testosterone replacement drug, Xyosted, the stock 8/03/15 Approved Version for 2016 PreAuth . 17-Apha Hydroxprogesterone Caproate (17P) and Makena® Information 17-alpha-hydroxyprogesterone caproate, commonly called 17P when made in a compounding pharmacy and Makena® when the medicine is manufactured, may be indicated for women who Will the weekly injections be administered between 16 weeks 0 days and 36 weeks 6 days of gestation? M Yes M No Please add any other supporting medical information that may be useful in the decision-making process: Makena is a weekly injection administered by a healthcare provider, starting as early as week 16 of the pregnancy, and given weekly until week 37 or the baby is born, whichever occurs first. This medicine is given only to pregnant women who are pregnant with one baby and Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy (a pregnancy with only one baby) who have a history of singleton spontaneous preterm birth. Medica requires prior authorization for certain drugs administered under a Medica member's medical benefit. 00! I recently ordered makena injections for my current pregnancy but when I received information in the mail from the company I promptly canceled the order. The provider purchases the product up front (from a distributor, specialty pharmacy, etc. A monthly notice of recently approved and/or revised Medical Policies, Medical Benefit Drug Policies, Coverage Determination Guidelines (CDGs), Utilization Review Guidelines (URGs) and Quality of Care Guidelines (QOCGs) is provided below for your review. Makena helps reduce the risk of preterm birth in the indicated patient population. The most common adverse reactions reported with Makena auto-injector use was injection site pain. The following dosage is an average dose and could differ among individuals. Makena is a progestin indicated to reduce the risk of preterm birth in . Dosing is once weekly with Dosing is once weekly with treatment starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation for 17 to 21 weeks. Read the Patient Information Leaflet if available from your pharmacist before you start using hydroxyprogesterone and each time you get a refill. A total of 463 pregnant women were randomized to receive either Makena (N=310) or vehicle (N=153) at a dose of 250 mg administered weekly by intramuscular injection starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation, and continuing until 37 weeks of gestation or delivery. For additional information about the medical benefit, please visit TMHP or call the TMHP Contact Center at 1-800-925-9126. 1 mL) in the back of the upper arm and when Makena was dosed IM (1 mL) in the upper outer quadrant of the gluteus maximus. 1 of 3 ANTARES PHARMA ANNOUNCES FDA APPROVAL OF PARTNER’S PRODUCT UTILIZING OUR QUICKSHOT AUTO INJECTOR AMAG Pharmaceuticals Makena® Subcutaneous Auto-Injector Approved To Reduce The Risk Of Preterm Birth In Certain At-Risk WomenMakena is a form of progesterone typically administered as an injection. For information on reimbursement, coding and rates, Makena® (17P) Enrollment Form Makena® (17P) (hydroxyprogesterone caproate injection) Supplies Needed (if medication is to be administered in patient’s . Billing Instructions for Makena . State of Oklahoma Oklahoma Health Care Authority Prior Authorization Form: Makena® (17-hydroxyprogesterone caproate), Crinone® (progesterone gel), and Endometrin® (progesterone vaginal insert) Pharm – 23 OHCA Approved – 07/31/2018exposure of hydroxyprogesterone caproate was seen when Makena was administered SC with the auto-injector (1. Although it is intended to be accurate, neither Walgreen Co. Makena is administered by a healthcare provider either subcutaneously via an auto-injector or intramuscularly once a week (every 7 days). However, there are some drugs that are for health care provider administration only. For Members: The services, items and drugs listed below require a prior authorization in order to be covered. State of Oklahoma Oklahoma Health Care Authority Prior Authorization Form: Makena® (17-hydroxyprogesterone caproate), Crinone® (progesterone gel), and Endometrin® (progesterone vaginal insert) exposure of hydroxyprogesterone caproate was seen when Makena was administered SC with the auto-injector (1. Makena Administered in Office: For questions about Makena, please call: 1-800-847-3418 and ask for a Louisiana Representative or email Makena@sonexushealth. Weekly injections of Makena may be administered in your home by a trained healthcare professional, if approved by your insurance plan. Makena auto-injector is a single-use, pre-filled, disposable device containing a 27 gauge, 0. Follow your medical professional's directions for best results. QS-T Makena® is approved in women to reduce the risk of preterm birth with singleton pregnancy and a history of spontaneous singleton preterm birth. Find out more > “Receiving the weekly injections of Makena is giving me the peace of mind knowing that I’m doing everything I can to help prolong this pregnancy. 1 mL) in the back of the upper arm and when Makena was dosed IM (1 mL) in the upper outer quadrant of the gluteus maximus. Makena administered subcutaneously demonstrated bioequivalence to the IM injection on area under the curve (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL), with the 90 percent confidence Notably, Makena administered subcutaneously via the auto-injector demonstrated bioequivalence for area under the curve (AUC 0-to-inf 2,386 ng/mL compared to 2,086 ng/mL for the IM injection), a key PK parameter, with the 90 percent confidence interval for the ratio of AUC (105. substitute for professional medical advice. This request should be fulfilled via Caremark Medical Specialty in Monroeville, Pennsylvania (NPI: 1043382302), Entrust Rx, or buy and bill. Started Makena (intramuscular) injections at 16wks +2 days. The brand name Makena requires a prior authorization and the following criteria for coverage: Two progesterone dosage forms are used to reduce pre-term labor––natural progesterone administered vaginally, and 17-alpha hydroxyprogesterone caproate (17P), a synthetic pro-gestin, administered via the intramuscular (IM) route. The Minnesota Department of Human Services (“Department”) supports the …Welcome to November 2018! As the year comes to an end, this season calls for planning and preparation for the upcoming year. For questions about For questions about a PA request, call Amerigroup Provider Services at 1-800-454-3730. Note: Oral and intravaginal formulations of progesterone are not addressed in this policy and should be obtained How to use Makena Vial. Members may not self-administer either a 17P compound injection or a Makena injection. Following the FDA approval of Makena subcutaneous February 14, the company is set to attain profitability in 2018. If you have any questions Makena (hydroxyprogesterone) is a form of progestin, a manmade form of a female hormone called progesterone. If significant improvement does not occur within 15 to 30 minutes, a second dose of 0. Makena® is approved in women to reduce the risk of preterm birth with singleton pregnancy and a history of spontaneous singleton preterm birth. 1 mL) once weekly (every 7 days) in the back of either upper arm by a healthcare provider. All of these women received hydroxyprogesterone caproate (Makena), self-administered compounded 17P, or nurse-administered compounded 17P in the home. Makena costs approximately $15,000 per pregnancy × 200 treated patients = $3,000,000 total cost. via subcutaneous auto-injector to Makena administered as an intramuscular injection were evaluated for safety. J1726 is a valid 2018 HCPCS code for Injection, hydroxyprogesterone caproate, (makena), 10 mg or just “ Makena, 10 mg ” for short, used in Medical care . Makena (hydroxyprogesterone caproate) is a non-preferred product and will only be considered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. 5-inch needle for administration. In addition, some vitamins and minerals and home health supply products are also available as a pharmacy benefit. 25 mg can be administered. Phone: 1-866-503-0857 Makena (Hydroxyprogesterone Caproate Injection) Prior Authorization Form Makena . Injectable Xiaflex ® (clostridial collagenase) is considered investigational for all other indications including, but not limited to, adhesive capsulitis. Intramuscular injection (Makena single-use and multi-dose vials ONLY): Draw up 1 mL (250 mg) of drug from the multi-dose glass vial into a 3-mL syringe with an 18-gauge needle, then change the needle to a 21-gauge 1. 17 Alpha Hydroxyprogesterone . eMedNY 2017 ICD-10 Update Testing Opening September, 2016 On September 6, 2016, eMedNY's Provider Testing Environment (PTE) will be available for submitters to begin testing their Medicaid claims with updated 2017 ICD-10 diagnosis codes and their inpatient hospital claims that utilize updated 2017 ICD-10 procedure codes. ” 10 Makena was approved via an accelerated approval process based on improvement Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal WomenMakena 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. Makena and the compounded version of 17P will continue to be available as a Medicaid medical benefit. According to the Makena prescribing information, treatment should begin between 16 weeks, 0 days Provider-administered specialty pharmacy products are ordered by a provider and administered in an office or outpatient setting. Any prior authorization procedures for such drugs must be administered in accordance with Section Makena® is approved in women to reduce the risk of preterm birth with singleton pregnancy and a history of spontaneous singleton preterm birth. TennCare Select CoverKids ® Provider-Administered Specialty Pharmacy Products . If it is necessary for a patient to take the brand Makena rather than the compounded version 17P, Makena is medically necessary if the medical criteria is met and it is administered in the physician’s office. Each expecting mother who has been prescribed Makena and enrolls (at no additional cost) in My Adherence Program will be paired with a dedicated maternal Makena™, 17-alpha hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and hydroxy progesterone. Continue until 37 weeks (last injection as late as week 366) or delivery, whichever occurs first. The purpose of this study was to evaluate the bioavailability of hydroxyprogesterone caproate (HPC) administered as a subcutaneous injection in the back of the upper arm using a prefilled autoinjector syringe with a 27-gauge needle compared with standard intramuscular injection in the gluteus maximus using a 21-gauge needle. The approval was based on the premise that because 17P is a sterile injectable drug, a product approved according to FDA guidelines would provide “greater assurance of safety. This program is often referred to as “buy and bill”. Buy) Efficacy for the sub-Q administered version of Makena is expected to be stellar and superior to deep muscle administered efficacy. Note: Oral and intravaginal formulations of progesterone are not addressed in this policy and should be obtained CURRENT THERAPY. 39) falling within the 80 to 125 percent range. Assume that 200 patients experienced a previous preterm birth. clostridium histolyticum can be administered in an office setting. 35 is spent to save $1. My last child was born at 36 weeks so I was on the fence in the first place. 35. I wanted to be brave and do it myself(vs having hubby do it as usual). Makena can either be administered: In the healthcare provider’s office, or; At home during a home healthcare visit (if covered by the patient’s insurance) Makena (hydroxyprogesterone) is a form of progestin, a manmade form of a female hormone called progesterone. 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 drugs on the list below need to be ordered by a provider and administered in an office or outpatient setting. The recommended dose of Makena (vial) is 250 mg administered once weekly into the upper, outer area of the buttock. 1 mL) once weekly, in the back of either upper arm Makena (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 ( 2. Makena is a once weekly treatment administered by a Makena dosage is dependent on the individual that it is being administered to. Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Prices and coupons for Makena This prescription is provided by a doctor and is generally not available at a pharmacy. Antares: Makena Has the Potential to Make a Very Significant Contribution to EPS (ATRS, $0. The “Instructions for Use” contains detailed steps for administering the subcutaneous injection using the auto-injector [see Instructions For Use (Makena Learn more about Makena: What it is, if it's right for you, the administration options, and what the possible side effects are. Makena is administered either by IM, at a dose of 250 mg (1 mL), or by SC, at a dose of 275 mg (1. An updated "Medicaid Transportation Justification Request "(Form 2015) or 'Medicaid Transportation Standing Order Request for Appointments Occurring 3 Days or More Per Week" (Form 2015-SO) are available on both web sites listed above, or upon request. This drug is administered by your healthcare practitioner (HCP), which usually means: Prior authorization for professionally administered drugs Some drugs require prior authorization before they can be delivered or administered in a physician’s office, clinic, outpatient or home setting. cover both Makena ® administered through the “buy and bill” process. For these medications, you'll need to go in to yourSome drugs require precertification before they can be delivered or administered in a physician's office, clinic, outpatient or home setting. The Minnesota Department of Human Services (“Department”) supports the …. for administering your injectable medication. Note : Oral and intravaginal formulations of progesterone are not addressed in this policy and should be obtained Will the weekly injections be administered between 16 weeks 0 days and 36 weeks 6 days of gestation? M Yes M No Please add any other supporting medical information that may be useful in the decision-making process: MHTPA121115-95. To create a standardized formulation of 17P, the FDA approved Makena (KV Pharmaceutical Company), an orphan drug, on February 4, 2011. Begin once-weekly (every 7 days) injections of Makena between weeks 160 and 206. Prior authorization requests must indicate the total number of doses to be For Makena® SubQ autoinjector: Initial dose must be administered by a healthcare professional; AND Member and caregiver must be trained by a healthcare professional on SubQ administration and storage of Makena® SubQ autoinjector. Divide the total cost by the savings, and the ROI comes out to negative $2. The recommended dose of Makena (auto-injector) is 275 mg administered once weekly in the back of either arm. It is used in pregnant women to help lower the risk of giving birth too early (preterm birth or giving birth less than 37 weeks of pregnancy). Effective January 1, 2016 . After receiving a CRL for its testosterone re It is administered once-weekly Makena is administered intramuscularly at a dose of 250 mg (1ml) once a week (every 7 days). The women were randomized to receive either Makena or vehicle at a dose of 250 mg administered weekly by intramuscular injection starting between 16 A total of 463 pregnant women were randomized to receive either Makena (N=310) or vehicle (N=153) at a dose of 250 mg administered weekly by intramuscular injection starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation, and continuing until 37 weeks of gestation or delivery. 85. Authorizations are based on medical necessity, which is determined by the drug **This medication is administered through syringe/needle & requires reconstitution ** Crinone 8%® Is a progesterone gel, which helps to prepare the uterus for embryo implantation and support pregnancy once implantation has occurred. • Currently administered IM with a large-gauge needle from a single dose vial, QuickShot® product administered sub-Q through a fine-gauge nonvisible needle Makena® sNDA approved by FDA February 14, 2018 17-alpha-hydroxyprogesterone caproate, commonly called 17P, may also be referred to as 17- OHP, 17-OHPC, 17Pc, Makena™, 17-alpha hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and hydroxy progesterone. The press release commented on the data as follows: “Makena administered subcutaneously demonstrated bioequivalence to the IM injection on area under the curve (AUC 0-to-inf 2,386 ng/mL compared to 2,086 ng/mL), with the 90 percent confidence interval for the ratio of AUC (105. Makena is a once weekly treatment administered by a The women were randomized to receive either Makena or vehicle at a dose of 250 mg administered weekly by intramuscular injection starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation, and continuing until 37 weeks of gestation or delivery. 25 mg subcutaneously into the lateral deltoid area. Attestation to Administer Makena Injections Makena, or hydroxyprogesterone caproate injection, is a progestin indicated to reduce the risk of preterm Makena is administered once weekly by a healthcare Makena with NDC 64011-243 is a a human prescription drug product labeled by Amag Pharmaceuticals, Inc. Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women Purpose. To begin the process, follow the instructions on the Makena Referral Prescription Form. The 17P compound injection and the Makena injection are provider-administered drugs and must be administered by a medical professional. Makena Care Connection does have a patient assistance program and provides Makena to uninsured patients. As a result of the high cost of Makena, $2. Makena Administered in Office: For questions about Makena, please call: 1-800-847-3418 and ask for a Louisiana Representative or email Makena@sonexushealth. . The advantage of nurse-administered injections is that compliance can be monitored Drugs administered other than oral method, chemotherapy drugs HCPCS Code J1726 is a newly added HCPCS code for 2018 and effective Jan 01, 2018. 7% weekly market share for Intrarosa, which has grown to weekly market share of 2. 8% by the close of the first quarter of 2018. ” —Katie, mom of a 34-week preemie Indication. 39) falling within the 80 to 125 percent range, which The study demonstrated bioequivalence for Makena administered subcutaneously via the auto-injector compared to the IM injection in a key pharmacokinetic parameter. A total of 463 pregnant women were randomized to receive either Makena (N=310) or vehicle (N=153) at a dose of 250 mg administered weekly by intramuscular injection starting between 16 weeks, 0 days and 20 weeks, 6 days of gestation, and continuing until 37 weeks of gestation or delivery. com Steps to take when Makena is administered at your office When you purchase Makena on your own, submit a claim for reimbursement, or get it from one of the UnitedHealthcare Community Plan’s network specialty pharmacies: Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women HCPCS code J1726 for Injection, hydroxyprogesterone caproate, (makena), 10 mg as maintained by CMS falls under Drugs, Administered by Injection . Makena administration produced embryolethality in rhesus monkeys but not in. Usual Adult Dose for Asthma - Acute. 1 mL), once weekly by a healthcare provider. Administer to the upper outer quadrant of the gluteus maximus. This medication is for the use of adult females. The majority of drugs your doctor prescribes for you will be self-administered, meaning you'll fill your prescription at the pharmacy and take your medication yourself, at home. Nevada Medicaid and Nevada Check Up News (Third Quarter 2018 Provider Newsletter) []Behavioral Health Providers Invited to Attend Monthly DHCFP Webinars [See Web Announcement 1628]. Pharmacy Prior Authorization. g. Today, I received my first order of auto-injectors. , Makena is administered intramuscularly at a dose of 250 mg (1ml) once a week (every 7 days). The Texas Medicaid formulary includes all legend and over-the-counter drugs. is prescribed to Makena will be administered by: The brand name Makena will be covered by Nebraska Medicaid as a physician administered injectable medication beginning with date of service April 1, 2013. Makena® is approved in women to reduce the risk of preterm birth with singleton pregnancy and a history of spontaneous singleton preterm birth. Makena is not intended Please note: Makena is covered under the medical benefit only. Missing information makes it difficult to approve requests and creates a longer processing time. ), then submits a claim to Medicaid when the product is administered to the patient. Indication. Includes dose adjustments, warnings and precautions. Makena is not intended Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy (a pregnancy with only one baby) who have a history of singleton spontaneous preterm birth. 5 inch needle that delivers one dose subcutaneously in the back of the upper arm. Medical Prior Authorization List . Since its inception, plans administered by CSMG and its affiliates and are derived from literature based on and supported by applicable federal or state coverage mandates, clinical guidelines, nationally recognized utilization and technology assessment guidelines, other Makena administered subcutaneously demonstrated bioequivalence to the IM injection on area under the curve (AUC 0-to-inf 2,386 ng/mL compared to 2,086 ng/mL), with the 90 percent confidence The study demonstrated bioequivalence for Makena administered subcutaneously via the auto-injector compared to the IM injection in a key pharmacokinetic parameter. Hydroxyprogesterone caproate (OHPC), sold under the brand names Proluton and Makena among others, is a progestin medication which is used to prevent preterm birth in pregnant women with a history of the condition and to treat gynecological disorders