ALYQ (Page 6 of 7)

14.2 Long-Term Treatment of Pulmonary Arterial Hypertension

Patients (N=357) from the placebo-controlled study entered a long-term extension study. Of these, 311 patients have been treated with tadalafil for at least 6 months and 182 for 1 year (median exposure 356 days; range 2 days to 415 days). The survival rate in the extension study was 96.5 per 100 patient years. Without a control group, these data must be interpreted cautiously.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ALYQ™ (tadalafil tablets USP) is supplied as follows:

20 mg orange, oval-shaped, film-coated tablets (not scored), debossed with “TEVA” on one side and with “3334” on the other side of the tablet in bottles of 60 (NDC 0093-3334-06).

16.2 Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling (Patient Information)

  • Inform patients of contraindication of ALYQ™ with any use of organic nitrates or GC stimulators.
  • Inform patients that tadalafil is also marketed as CIALIS® for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking ALYQ™ not to take CIALIS® or other PDE5 inhibitors.
  • Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking ALYQ™. Such an event may be a sign of NAION. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.
  • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking ALYQ™. These events may be accompanied by tinnitus and dizziness.

Brands listed are the trademarks of their respective owners.

Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. A 9/2021

PATIENT INFORMATION

ALYQ™ (ah-LIQ)

(tadalafil) tablets

Read this patient information before you start taking ALYQ™ and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about ALYQ™?

Never take ALYQ™ with any nitrate or guanylate cyclase stimulator medicines:

  • Your blood pressure could drop quickly to an unsafe level
  • You could get dizzy, faint and even have a heart attack or stroke.

Nitrates include:

  • Medicines that treat chest pain (angina)
  • Nitroglycerin in any form including tablets, patches, sprays, and ointments
  • Other nitrate medicines (isosorbide mononitrate or dinitrate)
  • Street drugs that are inhaled, called “poppers” (amyl nitrate, butyl nitrate or nitrite)

Guanylate cyclase stimulators include:

  • Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension

Ask your healthcare provider or pharmacist if you are not sure if you take a nitrate or guanylate cyclase stimulator medicine.

What is ALYQ™?

ALYQ™ is a prescription medicine used to treat pulmonary arterial hypertension (PAH, high blood pressure in your lungs) to improve your ability to exercise.

It is not known if ALYQ™ is safe or effective in children.

Who should not take ALYQ™?

Do not take ALYQ™ if you

  • take any medicines called nitrates.
  • use recreational drugs called “poppers” like amyl nitrate, butyl nitrate or nitrite.
  • take any medicines called guanylate cyclase stimulators
  • are allergic to tadalafil or any other ingredient in ALYQ™. See “What are the ingredients in ALYQ™?” at the end of this leaflet.

See “What is the most important information I should know about ALYQ™?”

What should I tell my healthcare provider before taking ALYQ™?

Before taking ALYQ™, tell your healthcare provider about all of your medical conditions, including if you:

  • are allergic to ALYQ™ or CIALIS® or any of its ingredients. See the end of this leaflet for a complete list of ingredients in ALYQ™.
  • have pulmonary veno-occlusive disease (PVOD)
  • have heart problems
  • have low blood pressure
  • have liver problems
  • have kidney problems or get dialysis
  • have retinitis pigmentosa, a rare genetic eye disease
  • have ever had any sudden vision loss, including any damage to your optic nerve or NAION.
  • have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing
  • have a deformed penis shape or Peyronie’s disease
  • have had an erection that lasted more than 4 hours
  • have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
  • are pregnant or planning to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breast feed. If you breastfeed while taking ALYQ™, it is likely that ALYQ™ will pass into your breast milk. You and your healthcare provider should decide if you will take ALYQ™ or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ALYQ™ and other medicines may affect each other.

Especially tell your healthcare provider if you take any of these medicines*:

  • nitrates or guanylate cyclase stimulators (see “What is the most important information I should know about ALYQ™?”)
  • alpha blockers, used to treat prostate disease and high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint.
  • protease inhibitors, used to treat HIV infection, such as ritonavir (Norvir® , Kaletra®)
  • ketoconazole (Extina® , Xolegel® , Ketozole® , Nizoral A-D® , Nizoral®) itraconazole (Sporanox®)
  • erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine)
  • rifampin (Rifadin® , Rifamate® , Rifater® , Rimactane®)
  • bosentan (Tracleer®)
  • phenobarbital, phenytoin (Dilantin®), carbamazepine (Tegretol®)
  • CIALIS® or other medicines or treatments for erectile dysfunction (impotence).
  • Tadalafil is also marketed as CIALIS® for the treatment of male erectile dysfunction (ED, impotence) and for the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). Do not take both ALYQ™ and CIALIS®. Do not take ALYQ™ and other medicines or treatments for erectile dysfunction.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take ALYQ™?

  • Take ALYQ™ exactly as your healthcare provider tells you.
  • Take ALYQ™ tablets at the same time every day. You should take both tablets at the same time, one after the other, every day. Do not split your dose.
  • ALYQ™ can be taken with or without food.
  • Do not change your dose or stop taking ALYQ™ without speaking to your healthcare provider.
  • If you take too much ALYQ™, call your healthcare provider or go to an emergency department right away.

What should I avoid while taking ALYQ™?

Do not have more than 4 alcohol-containing drinks in a short period of time while you take ALYQ™. Drinking too much alcohol can lower your blood pressure. You could get dizzy or faint.

What are the possible side effects of ALYQ™?

The following side effects were reported rarely in patients taking tadalafil:

  • Decreased eyesight or loss of vision in one or both eyes (NAION). If you notice a sudden decrease or loss of vision in one or both eyes, contact a healthcare provider right away.
  • Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you notice a sudden decrease or loss of hearing, contact a healthcare provider right away.
  • In men, an erection that lasts more than 4 hours (with or without pain). Talk to your healthcare provider or go to the emergency department right away. An erection that lasts more than 4 hours must be treated as soon as possible or you can have lasting damage to your penis, including the inability to have erections.

See “What is the most important information I should know about ALYQ™?”

The most common side effects with ALYQ™ include:

  • headache
  • muscle pain
  • getting red or hot in the face (flushing)
  • nausea
  • pain in the arms, legs, or back
  • upset stomach
  • stuffy or congested nose

Tell your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects of ALYQ™. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store ALYQ™?

Store ALYQ™ tablets at room temperature between 68° to 77°F (20° to 25°C).

Keep ALYQ™ and all medicines out of the reach of children.

General Information about the safe and effective use of ALYQ™

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ALYQ™ for a condition for which it was not prescribed. Do not give ALYQ™ to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about ALYQ™. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ALYQ™ that is written for healthcare professionals. For more information, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.

What are the ingredients in ALYQ™?

Active Ingredient: tadalafil

Inactive Ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.

Rx only

Brands listed are the trademarks of their respective owners.

Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. A 9/2021

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