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FDA-Approved

From Azurity Pharmaceuticals, delivering high-quality medications specifically for pediatric patients.

CALCIUM CHANNEL BLOCKER

FDA-Approved

From Azurity Pharmaceuticals,
delivering high-quality medications
specifically for pediatric patients.

The First and Only FDA-Approved Amlodipine Oral Suspension for Hypertensive Pediatric Patients Age 6 Years and Older

Katerzia is a type of prescription medicine known as a calcium channel blocker (CCB).

It is used to:

  • treat high blood pressure (hypertension) in children 6 years of age and older, as well as adults.
  • treat coronary artery disease and a type of chest pain called angina in adults.
  • may be used by itself or with other medicines used to treat these conditions.

Katerzia is the first and only FDA-approved oral liquid form of a medicine called amlodipine. Because this medicine is approved by the U.S. Food and Drug Administration (FDA), you can rest assured it’s a high-quality product delivering excellent safety and effectiveness.

Katerzia Dosing Information

Ready to use. Simply shake before using.

Your doctor will tell you how much Katerzia you or the patient should take. Do not change the dose of Katerzia unless your doctor tells you to do so.

The effective antihypertensive oral dose to lower blood pressure in pediatric patients ages 6- to 17 years is 2.5 mg to 5 mg orally once daily. Doses of more than 5 mg daily have not been studied in pediatric patients.

  • Take Katerzia once a day, with or without food.
  • It may be easier if you take Katerzia at the same time every day, such as with breakfast, dinner, or at bedtime.
  • Do not take more than 1 dose of Katerzia at a time.
  • Always shake Katerzia before use and carefully measure the prescribed dose before you or the patient takes it.
  • Make sure you or the patient swallows the entire dose of Katerzia.
  • If you have questions about Katerzia, ask your doctor or your pharmacist.
  • Consult your doctor before making any changes to the medication or dose amount.
  • If you took too much Katerzia, call your doctor or the Poison Control Center, or have someone take you to the nearest hospital emergency room right away.

Missed a dose of Katerzia?

If you or the patient missed a dose of Katerzia, take it as soon as you remember. Unless it has been more than 12 hours, then wait and take the next does as scheduled. 

IMPORTANT: Ask your pharmacist for an accurate measuring device for use in administering Katerzia.

 

Eligible Patients May Pay No More Than $30 For Katerzia*

If you have commercial insurance, you may pay no more than $30 for your prescription with the Katerzia co-pay programs. The automatic savings is instantly applied to your co-pay at the pharmacy. It’s completely paperless, so there are no cards, coupons, or forms.

For eVoucherRx™ questions, please call: 800‐388‐2316 Relay Pharmacy Help Desk/Customer Support.* Or to see a list of participating pharmacies for eVoucherRx, visit http://evoucherrx.relayhealth.com/storelookup.

For Voucher On Demand™ questions, please call: 866-379-6389 eRx Network, LLC. Help Desk/Customer Support.*

*See Katerzia co-pay programs eligibility restrictions, terms, and conditions.

How do I use the Katerzia co-pay programs?

It’s easy. You don’t need any cards or coupons. Take your Katerzia prescription to one of many participating pharmacies nationwide. When you pick up your prescription, you’ll get an automatic co-pay reduction that ensures you’ll pay no more than $30 for Katerzia if your co-pay is $230 or less.

How much money will I save?

Qualifying patients will pay no more than $30 for a Katerzia prescription. Your savings depends on the amount of your co‐pay above $30.

*Eligibility Restrictions, Terms, and Conditions

By participating in this savings program, participants understand and agree that the information provided, as well as non-personally identifiable information obtained from the pharmacy, will be shared with the manufacturer and with any companies working with the manufacturer. Participants also affirm that they will not submit, and have not had submitted on their behalf, a claim for reimbursement or coverage for items purchased with this card under Medicaid, Medicare, TRICARE, or any other federal or state government healthcare program, or where prohibited by state law.

  • Offer applies to out‐of‐pocket expenses (co‐pay) greater than $30. Out‐of‐pocket expenses greater than $30 will be covered up to $230 per prescription. If your total out‐of‐pocket cost exceeds $230, you will be responsible for a $30 co‐pay plus any additional amount over $230. If your co‐pay is already $30 or less, this offer does not apply.
  • Offer applies only to Katerzia patients and associated refills.
  • This offer is not valid for prescriptions paid in part or in full by any federally or state‐funded program, including but not limited to Medicaid, Medicare, Department of Veterans Affairs, Department of Defense, or TRICARE, and where prohibited by law.
  • For questions about eVoucherRx™, please call: 800‐388‐2316 Relay Pharmacy Help Desk/Customer Support.
  • For questions about Voucher On Demand™, please call: 866‐379‐6389 eRxNetwork, LLC Help Desk/Customer Support.
  • This savings program cannot be combined with any other coupon, certificate, voucher, or similar offer.
  • Offer good only in the USA at participating retail pharmacies and cannot be redeemed at government‐subsidized clinics. Void where taxed, restricted, or prohibited by law.
  • Offer not extended to clubs, groups, or organizations.
  • Participation in this program must comply with all applicable laws and contractual or other obligations as a pharmacy provider.
  • This is not an insurance program.
  • Participating patients and pharmacists understand and agree to comply with the Terms and Conditions of this offer as set forth herein.
  • Any step‐edits or prior authorizations required by the insurance plan still apply.
  • Azurity Pharmaceuticals, Inc. reserves the right to modify or cancel this program at any time.
  • eVoucherRx™ and Voucher On Demand™ are not extended on prescriptions for patients:
    • who are cash‐paying customers.
    • using institution-based pharmacies to fill their prescriptions, or who are recipients of federal or state government health care.
    • who are filling their prescriptions at nonparticipating pharmacies.

eVoucherRx™ is a trademark of RelayHealth.
Voucher On Demand™ is a trademark of eRxNetwork, LLC.

Important Safety Information

INDICATIONS

  • KATERZIA is a type of prescription medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina.
  • May be used in adults and children 6 years of age and older to lower blood pressure.
  • Can be used by itself or with other medicines to treat these conditions.

Katerzia may cause side effects. See additional Important Safety Information below.

 ADDITIONAL IMPORTANT SAFETY INFORMATION

Before you or the patient takes Katerzia, tell your doctor if you or the patient has ever had heart disease or liver problems, or are pregnant, planning to become pregnant, or are breastfeeding.

 WHO SHOULD NOT USE KATERZIA? 

Do not use Katerzia if you or the patient is allergic to amlodipine, the active ingredient in Katerzia, or to the inactive ingredients in Katerzia. Your doctor or pharmacist can give you a list of these ingredients.

Warnings/Precautions

  • Symptoms of low blood pressure (hypotension) are possible, particularly in patients with serious heart valve disease (severe aortic stenosis). However, acute low blood pressure is unlikely.
  • Worsening chest pain called angina and heart attack (acute myocardial infarction) can develop after starting or increasing the dose of Katerzia, particularly in patients with severe obstructive coronary artery disease.
  • Patients with severe liver disease may need to start with a lower initial dose of Katerzia.

Katerzia may cause the following side effects. Most side effects are mild or moderate.

  • Edema (swelling of your legs or ankles)
  • Dizziness
  • Flushing (hot or warm feeling in your face)
  • Palpitations (rapid heartbeat)
  • Tiredness (fatigue)
  • Nausea, stomach pain
  • Sleepiness (somnolence)

These are not all the possible side effects of Katerzia. Your doctor or your patient’s doctor is the best source of advice about side effects. Call the doctor immediately if you or your patient has any side effects that concern you or do not go away.

Make sure you or your patient visits the doctor regularly.

Tell your doctor about any prescriptions or over the counter drugs you take, including vitamins and natural or herbal supplements. 

Limitations in Specific Populations

  • Limited information on Katerzia use in pregnant women does not show a drug-associated risk for major birth defects or miscarriage. There are risks to mother and fetus if high blood pressure during pregnancy is not controlled.
  • The usual dose of Katerzia to lower blood pressure in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg orally once daily. Doses of more than 5 mg daily have not been studied in pediatric patients and the effect of amlodipine on blood pressure in patients under 6 years of age is not known.
  • In general, geriatric patients should start with a lower initial dose of Katerzia.
  • Patients with liver problems may need to start with a lower initial dose of Katerzia.
  • Limited information shows that Katerzia is present in human milk in a low amount (4.2%). No side effects from Katerzia have been observed in breastfed infants.

How Supplied

Katerzia is supplied as 150 mL in a 185 mL high-density polyethylene (HDPE) bottle with a child-resistant cap and tamper-evident seal.

Storage Information

Must store refrigerated at 2°C to 8°C/36°F to 46°F. Avoid freezing and excessive heat. Protect from light. Keep Katerzia away from children.

See full Prescribing Information for complete information.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

Keep this and all medications out of the reach of children.