Product Description

PIRFENEX 200 MG (PIRFENIDONE)

WHAT IS PIRFENIDONE (PIRFENEX 200 MG)?

Pirfenidone is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).

FDA approval of two new drugs for idiopathic pulmonary fibrosis (Esbriet and Ofev) offers new hope for patients who live with this deadly, incurable disease.

The U.S. Food and Drug Administration has approved Esbriet (pirfenidone), a TGF-beta synthesis inhibitor for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

USES OF PIRFENEX 200 MG (PIRFENIDONE) TABLETS.

HOW PIRFENEX 200 MG (PIRFENIDONE) TABLET WORKS

COMMON SIDE EFFECTS OF  PIRFENEX 200 MG (PIRFENIDONE) TABLETS

BEFORE TAKING PIRFENIDONE (PIRFENEX 200 MG):

Before you start treatment, tell your doctor if you:

• Have liver problems
• Have kidney problems
• Are a smoker
• Have any other medical conditions
• Are pregnant or plan to become pregnant. It is not known if the drug will harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if the drug passes into your breast milk. You and your doctor should decide if you will take Pirfenidone or breastfeed.

Tell your doctor about all the medicines you take, including prescription and over-the­counter medicines, vitamins, and herbal supplements.

HOW SHOULD I TAKE PIRFENIDONE (PIRFENEX 200 MG)?

• Take this medicine exactly as your doctor tells you to take it.
• Your doctor may change your dosage as needed.
• Take the medication with food. This may help to decrease nausea and dizziness.
• If you miss a dose, take your next dose as soon as you remember.
• Do not take two doses at the same time to make up for your missed dose.
• Do not take more than three doses each day.
• If you overdose, call your doctor or go to the nearest hospital emergency room right away.
• Your doctor should do certain blood tests before you start treatment.

WHAT SHOULD I AVOID WHILE TAKING PIRFENIDONE (PIRFENEX 200 MG)?

• Avoid sunlight. Pirfenidone can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use a sunscreen (SPF50) and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn.
• Avoid smoking. Smoking may affect how well the medicine works.

WHAT IS THE SIDE EFFECTS FOR PIRFENIDONE (PIRFENEX 200 MG)?

Pirfenidone may cause serious side effects, including:

• Liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment.
• Sensitivity to sunlight (photosensitivity) and rash.
• Stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain may occur. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose.

The most common side effects include feeling tired, headache, dizziness, and decreased or loss of appetite.

These are not all the possible side effects. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may also report side effects to the FDA.

HOW SHOULD I STORE PIRFENIDONE (PIRFENEX 200 MG)?

• Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep in a tightly closed container.
• Safely throw away any Pirfenidone that is out of date or no longer needed.
• Keep all medicines out of the reach of children.

WHAT IS EXPERT ADVICE FOR PIRFENIDONE (PIRFENEX 200 MG)?

• Pirfenidone makes you more sensitive to sunlight (photosensitivity). Avoid the sun (including sunlamps) whilst taking pirfenidone. Wear sunblock daily and cover your arms, legs, and head to reduce exposure to sunlight.
• Do not take pirfenidone if you are currently taking any other medications such as tetracycline antibiotics, as they can make you more photosensitive.
• Do not take pirfenidone if you are currently taking any other medications such as fluvoxamine, it should be discontinued prior to the initiation of pirfenidone therapy and avoided during pirfenidone therapy.
• Avoid using pirfenidone if you are pregnant, breastfeeding, or planning to get pregnant.
• Avoid smoking or use tobacco products.
• Stop smoking while on and before beginning pirfenidone, as it can reduce the effect of pirfenidone.
• Pirfenidone may cause dizziness and tiredness. If you feel tired or dizzy be cautious while driving or operating machinery.
• Stop using pirfenidone and consult your doctor immediately if you experience a serious allergic (hypersensitivity) reaction characterized by swelling of the face, lips, and/or tongue, difficulty breathing or wheezing; or skin reaction to sunlight or sunlamps such as blistering and/or marked peeling of the skin.
• Avoid using pirfenidone if you feel ill and unwell and have yellowing of the eyes or skin, with or without dark urine, accompanied by itching of the skin; or if you get signs of an infection such as a sore throat, fever, mouth ulcers, or flu-like symptoms.

FREQUENTLY ASKED QUESTIONS FOR PIRFENIDONE (PIRFENEX 200 MG)

Pirfenidone