Making Prescribing Easy

KATERZIA MAKES PRESCRIBING EASY

AnovoRx Specialty Pharmacy offers comprehensive assistance – from prior authorization to product delivery.
Dedicated PA Hotline: 1-844-472-2032.

You will also gain access to a full suite of services, including:

Prior Authorization Assistance

Insurance Verification

Free Delivery and Overnight Shipping

Patient Assistance and Resources

Product Information and Expertise

Here’s How to Set Up Home Delivery for Your Patients

Patients can obtain Katerzia for home delivery. Healthcare providers simply submit Katerzia prescriptions by phone, fax, or e-prescribing (using the information below) to:

Attn: Silvergate PAP
1710 N. Shelby Oaks Dr. #1
Memphis, TN 38134
Phone: 1-844-472-2032
Fax: 1-866-927-2052

Download enrollment forms and get your patients started on Katerzia

Katerzia Patient Enrollment and Prescription Form

Katerzia Patient Assistance Program Form

IMPORTANT SAFETY INFORMATION

INDICATIONS

KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

  • Hypertension in adults and children 6 years of age and older, to lower blood pressure:
    • Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
  • Coronary Artery Disease:
    • Chronic stable angina.
    • Vasospastic angina (Prinzmetal’s or variant angina).
    • Angiographically documented coronary artery disease in patients without heart failure or an ejection fraction < 40%.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Contraindications:

Katerzia is contraindicated in patients with known sensitivity to amlodipine or to the inactive ingredients.

Warnings and Precautions:

  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
  • Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
  • Because amlodipine is extensively metabolized by the liver, and the plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering Katerzia to patients with severe hepatic impairment.

Adverse Reactions: See full Prescribing Information for additional adverse reactions.

  • The most common dose-related adverse reaction to amlodipine is edema.
  • Incidents of dose-related dizziness, flushing, and palpitation also have been observed.
  • For several reported adverse experiences that appear to be dose- and drug-related (edema, flushing, palpitations), there was a higher incidence associated with amlodipine treatment in women than in men.
  • Other adverse experiences not dose-related but reported are fatigue, nausea, abdominal pain, and somnolence.

Drug Interactions:

Impact of Amlodipine on Other Drugs

  • Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
  • Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended. Adjust the dose accordingly when appropriate.

Impact of Other Drugs on Amlodipine

  • Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.
  • Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.

Important Limitations in Specific Populations:

Pediatric Use

  • The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
  • The effect of amlodipine in patients less than 6 years of age is not known.

Geriatric Use

  • In general, dose selection for elderly patients should be cautious, usually starting with a lower initial dose.

Hepatic Impairment

  • A lower initial dose may be required for patients with hepatic insufficiency.

Pregnancy

  • Limited data on post-marketing use of amlodipine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriages. There are risks to the mother and fetus associated with poorly controlled hypertension during pregnancy. See full Prescribing Information.

Lactation

  • Limited available data from a published clinical lactation study reports that amlodipine is present in human milk. No adverse effects of amlodipine on the breastfed infant have been observed.

SHAKE BEFORE USING.

Refrigerate at 2°C to 8°C/36°F to 46°F. Avoid freezing and excessive heat. Protect from light.

Please see full Prescribing Information for complete information.

To report SUSPECTED ADVERSE REACTIONS, contact Silvergate 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.