Product Information
Dosage and Administration
Safety
Special/Other Topics
PRODUCT INFORMATION
What is the generic name of EXFORGE (X-PHORJ)?
The generic name of EXFORGE is amlodipine and valsartan tablets.
What is EXFORGE?
EXFORGE contains two prescription medicines in a single, once daily pill that work together in two different complementary ways to lower blood pressure: amlodipine (the active ingredient in Norvasc®), a calcium channel blocker, and valsartan (the active ingredient in Diovan®), an angiotensin II receptor blocker.
For what is EXFORGE indicated?
EXFORGE is indicated for the treatment of hypertension. EXFORGE should not be used before other medications have been tried first to treat high blood pressure.
When was EXFORGE approved by the FDA?
The Food and Drug Administration approved EXFORGE on June 20, 2007.
What type of medication is EXFORGE?
EXFORGE is a pill containing two prescription medications, amlodipine and valsartan. Amlodipine is a dihydropyridine calcium channel blocker, otherwise known as a CCB. Valsartan is an Angiotensin II receptor blocker, otherwise known as an ARB.
How does EXFORGE work?
Blood is carried from the heart to all parts of the body in vessels called arteries. Blood pressure is created by the force of the blood pushing against the walls of the arteries as it circulates and the force of the arteries as they resist the blood flow. You have high blood pressure when the force is too much. EXFORGE works in two different complementary ways to block substances in the body that can cause blood vessels to narrow, contributing to high blood pressure. EXFORGE can help your blood vessels relax so your blood pressure is lower.
In what strengths is EXFORGE available?
EXFORGE is available in four combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg
(The first number refers to the number of milligrams of amlodipine. The second number refers to the number of milligrams of valsartan.)
What are the ingredients of EXFORGE?
Active ingredients: amlodipine and valsartan.
The inactive ingredients of all strengths of the tablets are colloidal silicone dioxide, crospovidone, magnesium stearate and microcrystalline cellulose. Additionally the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc and titanium dioxide.
What does EXFORGE look like?
EXFORGE 5/160 mg Tablets – dark yellow, oval shaped, film coated tablet with beveled edge, debossed with "NVR" on one side and "ECE" on the other side.
EXFORGE 10/160 mg Tablets – light yellow, oval shaped, film coated tablet with beveled edge, debossed with "NVR" on one side and "UIC" on the other side.
EXFORGE 5/320 mg Tablets – very dark yellow, oval shaped, film coated tablet with beveled edge, debossed with "NVR" on one side and "CSF" on the other side.
EXFORGE 10/320 mg Tablets – dark yellow, oval shaped, film coated tablet with beveled edge, debossed with "NVR" on one side and "LUF" on the other side.
DOSAGE AND ADMINISTRATION
How do I take EXFORGE?
- Take EXFORGE exactly as your doctor tells you.
- Take EXFORGE at the same time each day, with or without food.
- If you miss a dose, take it as soon as you remember. If it is close to your next dose, wait and take your next dose at the regular time.
- If you take too much EXFORGE, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.
Can EXFORGE be taken with or without food?
You can take EXFORGE with or without food. Just remember to take it at approximately the same time every day.
When and how often should EXFORGE be taken?
Take EXFORGE exactly as your doctor prescribes. EXFORGE is usually taken once every day at the same time or as close to the same time as possible.
Can EXFORGE be cut or crushed?
No. EXFORGE should not be cut or crushed in any way. EXFORGE should be swallowed whole.
What should I do if I miss a dose?
If you miss a dose, take it as soon as you remember. If it is close to your next dose, wait and take your next dose at the regular time. As with any medication, EXFORGE should be taken exactly as directed by your doctor. Do not double dose.
Can I take an extra dose?
No. Continue taking EXFORGE as directed by your physician.
How should EXFORGE be stored?
- Store EXFORGE tablets at room temperature between 59° to 86°F.
- Keep EXFORGE in the original prescription bottle in a dry place.
- Keep EXFORGE and all medications out of the reach of children.
How soon can I expect to see improvement?
Results will vary for each patient. EXFORGE has been shown to achieve significant blood pressure lowering results in as soon as two weeks.
Can I stop taking EXFORGE if I feel better or if I get to my blood pressure goal?
No. Continue taking EXFORGE as directed by your physician. Some people stop taking their hypertension medication because they feel better and mistakenly believe that they no longer need the medication. Some stop because their blood pressure returns to normal with treatment and they mistakenly believe that they are "cured". Others stop taking their medication because they believe that it makes them feel worse or that it is too expensive.
Although there is no cure for hypertension, hypertension can be managed with medication. If you experience side effects from your medication or have other difficulties taking it as prescribed, contact your doctor or pharmacist to discuss the issue.
SAFETY
Has EXFORGE been studied in clinical trials?
The blood pressure–lowering effects of EXFORGE have been studied in many clinical trials that included over 5,000 patients with high blood pressure. The safety of EXFORGE has been evaluated in over 2,600 hypertensive patients; over 1,440 of these patients were treated for at least six months, and over 540 of these patients were treated for at least one year.
What are the possible side effects of EXFORGE?
The most common side effects that occur more frequently with EXFORGE than placebo (sugar pill) are:
- swelling (edema) of hands, and/or ankles, or feet
- nasal congestion, sore throat and discomfort when swallowing
- upper respiratory tract infection (head or chest cold)
- dizziness
EXFORGE may cause serious side effects including:
- Injury or death of unborn babies.
- low blood pressure (hypotension). Low blood pressure is most likely to happen if you also take water pills, are on a low salt diet, get dialysis treatments, have heart problems or get sick with vomiting or diarrhea. Lie down if you feel faint or dizzy. Call your doctor right away.
- more chest pain and heart attacks in people that already have severe heart problems. This may happen when you start EXFORGE or when there is an increase in your dose of EXFORGE. Get emergency help if you get worse chest pain or chest pain that does not go away.
- kidney problems. Kidney problems may get worse in people that already have kidney disease. Some people will have changes in blood tests for kidney function and need a lower dose of EXFORGE. Call your doctor if you get swelling in your feet, ankles, or hands or unexplained weight gain.
- laboratory blood changes in patients with congestive heart failure. In studies with valsartan, some patients with congestive heart failure had blood tests that showed increased potassium and decrease in kidney function.
- allergic reactions.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of EXFORGE. For more information, ask your doctor or pharmacist.
Can I take EXFORGE with other medications?
EXFORGE can be taken with many other medications. But, be sure to tell your doctor and pharmacist about all medications that you are taking or intend to take. Your doctor should decide whether you can take EXFORGE with other medications. These include:
- Other medications that a doctor has prescribed.
- All medications that you buy yourself without a prescription.
- Any herbal remedies that you may be taking.
Can I drink grapefruit juice while on EXFORGE?
The effect of grapefruit juice on EXFORGE has not been studied.
Does EXFORGE contain latex or gelatin?
EXFORGE does not contain latex or gelatin. Speak with your doctor if you have any questions or concerns.
Does EXFORGE contain gluten?
Novartis Pharmaceuticals Corporation does not knowingly or intentionally include gluten in its products. However, due to multi-sourcing of certain inactive ingredients we can not guarantee the absence of gluten from our products.
If I have lactose intolerance, can I take EXFORGE?
Yes. EXFORGE does not contain lactose.
Does EXFORGE contain dye?
No. EXFORGE does not contain dye. EXFORGE does contain iron oxide-based colorants.
Does EXFORGE contain iodine?
No. EXFORGE does not contain iodine.
If I need to stop taking EXFORGE, do I need to titrate it (wean it off slowly)?
You should consult your doctor and follow their direction.
Who should not take EXFORGE?
- EXFORGE can harm an unborn baby and even cause death. If you get pregnant, stop taking EXFORGE. Call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
- Do not take EXFORGE if you are allergic to any of its ingredients.
Can I take EXFORGE while pregnant or breast-feeding?
Pregnancy: EXFORGE should not be taken by women who are pregnant. Contact your physician immediately if you become pregnant. EXFORGE should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child.
Breast-Feeding: It is not known if EXFORGE passes into your breast milk. You should choose either to take EXFORGE or breast-feed, but not both.
If you are planning on becoming pregnant, discuss other treatment options with your doctor.
Is EXFORGE safe for use in children?
EXFORGE has not been studied in children under 18 years of age.
Why does EXFORGE have a black box warning?
Drugs that act on the renin angiotensin system – including angiotensin receptor blockers and angiotensin-converting enzyme inhibitors – should not be used in pregnant women due to the risk of injury or even death to the developing fetus. If you get pregnant, stop taking EXFORGE and call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
SPECIAL/OTHER TOPICS
What should I tell my doctor before taking EXFORGE?
Tell all your doctors and dentist you are taking EXFORGE if you:
- are going to have surgery or dental surgery
- go for kidney dialysis
- are hospitalized for any reason
Tell your doctor about all your medical conditions, including if:
- you have heart problems
- you have liver problems
- you have kidney problems
- are suffering vomiting or having a lot of diarrhea
- are pregnant or plan to become pregnant.
- are breast-feeding or plan to breast-feed. EXFORGE may pass into your milk.
- Do not breast-feed while you are taking EXFORGE.
Tell your doctor about all the medications you take, including prescription and nonprescription medications, vitamins, and herbal supplements. Some of your other medications and EXFORGE could affect each other, causing serious side effects.
Especially tell your doctor if you take:
- other medications for high blood pressure or a heart problem
- water pills (also called "diuretics")
- potassium supplements
- a salt substitute
If you are taking a beta-blocker medication and your doctor tells you to stop taking it while you are taking EXFORGE, follow your doctor's instructions very carefully to slowly and safely stop the beta-blocker medication. Stopping beta-blocker medications too quickly can cause chest pain, heart attack, abnormal heart rhythm or high blood pressure. Taking EXFORGE does not help to prevent these effects. If you do not know if you take a beta-blocker medication, contact your doctor or pharmacist.
Keep a list of your medications with you, including vitamins and natural or herbal remedies, to show your doctor or pharmacist. Some of your other medications and EXFORGE could affect each other, causing serious side effects. Your doctor or pharmacist will know what medications are safe to take together.
How much does EXFORGE cost?
There is usually quite a bit of variability on prices from one pharmacy to another. It is best to check the price with your pharmacy of choice.
Is there a patient assistance program for patients who cannot afford EXFORGE?
Novartis provides a Patient Assistance Programs for individuals that cannot afford certain Novartis medications. Novartis is also a sponsor of The TogetherRx Access Card. To find out if you qualify, please call the Novartis Savings Network at 800-245-5356.
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