Page 29 - Makena Auto-Injector Patient Storybook

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MAKENA safely and effectively. See full prescribing information for MAKENA.
MAKENA® (hydroxyprogesterone caproate injection) for intramuscular or subcutaneous use.
Initial U.S. Approval: 1956
CONTRAINDICATIONS
• Current or history of thrombosis or thromboembolic disorders (4)
• Known or suspected breast cancer, other hormone-sensitive cancer, or history of
these conditions (4)
• Undiagnosed abnormal vaginal bleeding unrelated to pregnancy (4) • Cholestatic jaundice of pregnancy (4)
• Liver tumors, benign or malignant, or active liver disease (4)
• Uncontrolled hypertension (4)
WARNINGS AND PRECAUTIONS
• Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs (5.1)
• Allergic reactions: Consider discontinuing if allergic reactions occur (5.2)
• Decreased glucose tolerance: Monitor prediabetic and diabetic women receiving
Makena (5.3)
• Fluid retention: Monitor women with conditions that may be affected by fluid
retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction (5.4) • Depression: Monitor women with a history of clinical depression; discontinue
Makena if depression recurs (5.5)
ADVERSE REACTIONS
• In a study where the Makena intramuscular injection was compared with placebo, the most common adverse reactions reported with Makena intramuscular injection (reported incidence in ≥ 2% of subjects and higher than in the control group) were: injection site reactions (pain [35%], swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%). (6.1)
• In studies where the Makena subcutaneous injection using auto-injector was compared with Makena intramuscular injection, the most common adverse reaction reported with Makena auto-injector use (and higher than with Makena intramuscular injection) was injection site pain (10% in one study and 34% in another). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact AMAG Pharmaceuticals at 1-877-411-2510 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
RECENT MAJOR CHANGES
Dosage and Administration, Dosing (2.1)
Dosage and Administration, Preparation & Administration
INDICATIONS AND USAGE
02/2018 (2.2) 02/2018
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 (1). The effectiveness of Makena is based on improvement in the proportion of women who delivered < 37 weeks of gestation (14). There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth. (1)
DOSAGE AND ADMINISTRATION
• Makena auto-injector: Administer subcutaneously using Makena auto-injector at a dose of 275 mg (1.1 mL) once weekly, in the back of either upper arm (2.1)
• 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 (2.1)
• Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation (2.1)
• Continue administration once weekly until week 37 (through 36 weeks, 6 days) of
gestation or delivery, whichever occurs first (2.1)
DOSAGE FORMS AND STRENGTHS
1.1 mL single-use auto-injector for subcutaneous use contains 275 mg of hydroxyprogesterone caproate (250 mg/mL) (3)
1 mL single-dose vial for intramuscular use contains 250 mg of hydroxyprogesterone caproate. (3)
5 mL multi-dose vial for intramuscular use contains 1250 mg of hydroxyprogesterone caproate (250 mg/mL). (3)
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
2.2 Preparation and Administration
2.3 Instructions for Use (Makena Auto-injector)
3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Disorders
5.2 Allergic Reactions
5.3 Decrease in Glucose Tolerance 5.4 Fluid Retention
5.5 Depression
5.6 Jaundice
5.7 Hypertension
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
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.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena 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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
• Makena auto-injector: Administer subcutaneously using auto-injector at a dose of 275 mg
(1.1 mL) once weekly (every 7 days) in the back of either upper arm by a healthcare provider
• Makena (single- and multi-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
• Begintreatmentbetween16weeks,0daysand20weeks,6daysofgestation
• Continueadministrationonceweeklyuntilweek37(through36weeks,6days)ofgestationor
delivery, whichever occurs first
2.2 Preparation and Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Makena is a clear, yellow 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:
Makena single-dose or multi-dose vials (intramuscular use only)
Makena single-dose or multi-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:
1. Clean the vial top with an alcohol swab before use.
2. Draw up 1 mL of drug into a 3 mL syringe with an 18 gauge needle.
3. Change the needle to a 21 gauge 11⁄2 inch needle.
4. 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. 5. Applying pressure to the injection site may minimize bruising and swelling.
If the 5 mL multi-dose vial is used, discard any unused product 5 weeks after first use.
Makena auto-injector (subcutaneous use only)
Makena auto-injector is a single-use, pre-filled, disposable device containing a 27 gauge, 0.5 inch needle that delivers one dose subcutaneously in the back of the upper arm.
Revised 02/2018
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.6 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Trial to Evaluate Reduction of Risk of Preterm Birth
14.2 Infant Follow-Up Safety Study
16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed
Because Makena auto-injector is preservative-free, once the cap is removed the device should be used immediately or discarded.
Rotate the injection site to the alternate arm from the previous week. Do not use in areas where the skin is tender, bruised, red, scaly, raised, thick, or hard. Avoid areas with scars, tattoos, or stretch marks.
The solution is viscous and oily. The auto-injector takes approximately 15 seconds to deliver the dose; when the viewing window is fully blocked (completely orange), the full dose has been administered.
The “Instructions for Use” contains detailed steps for administering the subcutaneous injection using the auto-injector [see Dosage and Administration (2.3)]. Read the “Instructions for Use” carefully before administering Makena auto-injector.
2.3 Instructions for Use (Makena Auto-injector)