www.esbriethcp.com Review:

Esbriet® (pirfenidone) for healthcare professionals - Find HCP information about Esbriet® (pirfenidone) and idiopathic pulmonary fibrosis, a progressive and irreversible fibrotic interstitial lung disease. Indication and Select Important Safety Information About Esbriet Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). Select Important Safety Information What should I tell my doctor before taking Esbriet? Before you take Esbriet, 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 Esbriet will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Esbriet passes into your breast milk. You and your doctor should decide if you will take Esbriet or breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while taking Esbriet? Avoid sunlight. Esbriet can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF 50) 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 Esbriet works. What are the possible side effects of Esbriet? Esbriet 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, or feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet. sensitivity to sunlight (photosensitivity) and rash. See “What should I avoid while taking Esbriet?” stomach problems. Esbriet may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose of Esbriet. The most common side effects of Esbriet include feeling tired, headache, dizziness, and decreased or loss of appetite. These are not all the possible side effects of Esbriet. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

  • https://www.esbriethcp.com/request-esbriet-information Request HCP Information About Esbriet® (pirfenidone) - Healthcare professionals can request more information about Esbriet® (pirfenidone), an FDA-approved prescription medicine for IPF treatment. Indication Esbriet® (pirfenidone) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Select Important Safety Information Elevated liver enzymes: Increases in ALT and AST >3x ULN have been reported in patients treated with Esbriet. Rarely these have been associated with concomitant elevations in bilirubin. Patients treated with Esbriet had a higher incidence of elevations in ALT or AST than placebo patients (3.7% vs 0.8%, respectively). No cases of liver transplant or death due to liver failure that were related to Esbriet have been reported. However. the combination of transaminase elevations and elevated bilirubin without evidence of obstruction is generally recognized as an important predictor of severe liver injury that could lead to death or the need for liver transplants in some patients. Conduct liver function tests (ALT, AST, and bilirubin) prior to initiating Esbriet, then monthly for the first 6 months and every 3 months thereafter. Dosage modifications or interruption may be necessary. Photosensitivity reaction or rash: Patients treated with Esbriet had a higher incidence of photosensitivity reactions (9%) compared with patients treated with placebo (1%). Patients should avoid or minimize exposure to sunlight (including sunlamps), use a sunblock (SPF 50 or higher), and wear clothing that protects against sun exposure. Patients should avoid concomitant medications that cause photosensitivity. Dosage reduction or discontinuation may be necessary. Gastrointestinal disorders: Gastrointestinal events of nausea, diarrhea, dyspepsia, vomiting, gastroesophageal reflux disease, and abdominal pain were more frequently reported in patients treated with Esbriet. Dosage reduction or interruption for gastrointestinal events was required in 18.5% of patients in the Esbriet 2403 mg/day group, as compared to 5.8% of patients in the placebo group; 2.2% of patients in the Esbriet 2403 mg/day group discontinued treatment due to a gastrointestinal event, as compared to 1.0% in the placebo group. The most common (>2%) gastrointestinal events that led to dosage reduction or interruption were nausea, diarrhea, vomiting, and dyspepsia. Dosage modifications may be necessary in some cases. Adverse reactions: The most common adverse reactions (≥10%) were nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastroesophageal reflux disease, sinusitis, insomnia, weight decreased and arthralgia. Drug interactions: Concomitant administration with strong inhibitors of CYP1A2 (eg, fluvoxamine) significantly increases systemic exposure of Esbriet and is not recommended. Discontinue prior to administration of Esbriet. If strong CYP1A2 inhibitors cannot be avoided, dosage reductions of Esbriet are recommended. Monitor for adverse reactions and consider discontinuation of Esbriet as needed. Concomitant administration of Esbriet and ciprofloxacin (a moderate inhibitor of CYP1A2) moderately increases exposure to Esbriet. If ciprofloxacin at the dosage of 750 mg twice daily cannot be avoided, dosage reductions are recommended. Monitor patients closely when ciprofloxacin is used. Agents that are moderate or strong inhibitors of both CYP1A2 and CYP isoenzymes involved in the metabolism of Esbriet should be avoided during treatment. The concomitant use of a CYP1A2 inducer may decrease the exposure of Esbriet, and may lead to loss of efficacy. Concornitant use of strong CYP1A2 inducers should be avoided. Specific populations: Esbriet should be used with caution in patients with mild to moderate (Child-Pugh Class A and B) hepatic impairment. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. The safety, efficacy, and pharmacokinetics of Esbriet have not been studied in patients with severe hepatic impairment. Esbriet is not recommended for use in patients with severe (Child-Pugh Class C) hepatic impairment. Esbriet should be used with caution in patients with mild (CLcr 50-80 mL/min). moderate (CLcr 30-50 mL/min), or severe (CLcr less than 30 mL/min) renal impairment. Monitor for adverse reactions and consider dosage modification or discontinuation of Esbriet as needed. The safety, efficacy, and pharmacokinetics of Esbriet have not been studied in patients with end-stage renal disease requiring dialysis. Use of Esbriet in patients with end-stage renal disease requiring dialysis is not recommended. Smoking causes decreased exposure to Esbriet, which may alter the efficacy profile of Esbriet. Instruct patients to stop smoking prior to treatment with Esbriet and to avoid smoking when using Esbriet. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
  • https://www.esbriethcp.com/safety-dosing Dosing and Safety | Esbriet® dosing (pirfenidone) - Healthcare professionals can review an established IPF management plan for Esbriet® (pirfenidone), and review Esbriet dosing and safety profile. Indication and Select Important Safety Information About Esbriet Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). Select Important Safety Information What should I tell my doctor before taking Esbriet? Before you take Esbriet, 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 Esbriet will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Esbriet passes into your breast milk. You and your doctor should decide if you will take Esbriet or breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while taking Esbriet? Avoid sunlight. Esbriet can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF 50) 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 Esbriet works. What are the possible side effects of Esbriet? Esbriet 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, or feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet. sensitivity to sunlight (photosensitivity) and rash. See “What should I avoid while taking Esbriet?” stomach problems. Esbriet may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose of Esbriet. The most common side effects of Esbriet include feeling tired, headache, dizziness, and decreased or loss of appetite. These are not all the possible side effects of Esbriet. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
  • https://www.esbriethcp.com/worldwide-esbriet-ipf-patient-experience Worldwide Esbriet® (pirfenidone) IPF Patient Experience - HCPs can review how Esbriet® (pirfenidone) has been approved outside the US since 2011 in IPF clinical trials and evaluated in more than 1400 subjects. Indication and Select Important Safety Information About Esbriet Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). Select Important Safety Information What should I tell my doctor before taking Esbriet? Before you take Esbriet, 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 Esbriet will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Esbriet passes into your breast milk. You and your doctor should decide if you will take Esbriet or breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while taking Esbriet? Avoid sunlight. Esbriet can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF 50) 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 Esbriet works. What are the possible side effects of Esbriet? Esbriet 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, or feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet. sensitivity to sunlight (photosensitivity) and rash. See “What should I avoid while taking Esbriet?” stomach problems. Esbriet may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose of Esbriet. The most common side effects of Esbriet include feeling tired, headache, dizziness, and decreased or loss of appetite. These are not all the possible side effects of Esbriet. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
  • https://www.esbriethcp.com/ipf-patient-assistance Esbriet® (pirfenidone) Patient Assistance for HCPs - Find IPF patient assistance resources including the Esbriet® (pirfenidone) Inspiration ProgramTM, which includes the Esbriet Patient Welcome Kit and more. Indication and Select Important Safety Information About Esbriet Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). Select Important Safety Information What should I tell my doctor before taking Esbriet? Before you take Esbriet, 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 Esbriet will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Esbriet passes into your breast milk. You and your doctor should decide if you will take Esbriet or breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while taking Esbriet? Avoid sunlight. Esbriet can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF 50) 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 Esbriet works. What are the possible side effects of Esbriet? Esbriet 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, or feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet. sensitivity to sunlight (photosensitivity) and rash. See “What should I avoid while taking Esbriet?” stomach problems. Esbriet may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose of Esbriet. The most common side effects of Esbriet include feeling tired, headache, dizziness, and decreased or loss of appetite. These are not all the possible side effects of Esbriet. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
  • https://www.esbriethcp.com/site-map Esbriet® (pirfenidone) HCP Site Map - Find the official Esbriet® (pirfenidone) HCP site map here. Indication and Select Important Safety Information About Esbriet Esbriet® (pirfenidone) is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). Select Important Safety Information What should I tell my doctor before taking Esbriet? Before you take Esbriet, 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 Esbriet will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Esbriet passes into your breast milk. You and your doctor should decide if you will take Esbriet or breastfeed. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while taking Esbriet? Avoid sunlight. Esbriet can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF 50) 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 Esbriet works. What are the possible side effects of Esbriet? Esbriet 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, or feeling tired. Your doctor will do blood tests to check how your liver is working during your treatment with Esbriet. sensitivity to sunlight (photosensitivity) and rash. See “What should I avoid while taking Esbriet?” stomach problems. Esbriet may cause stomach problems such as nausea, vomiting, diarrhea, indigestion, heartburn, and stomach pain. Tell your doctor right away if your stomach problems get worse or do not go away. Your doctor may need to change your dose of Esbriet. The most common side effects of Esbriet include feeling tired, headache, dizziness, and decreased or loss of appetite. These are not all the possible side effects of Esbriet. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

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