Entyvio

Before taking Entyvio, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Entyvio or to any of its ingredients
• have an infection, think you may have an infection or have infections that keep coming back
• have liver problems
• have tuberculosis (TB) or have been in close contact with someone with TB
• have recently received or are scheduled to receive a vaccine. Talk to your healthcare provider about bringing your vaccines up-to-date before starting treatment with Entyvio.
• are pregnant or plan to become pregnant. It is not known if Entyvio. will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving Entyvio.
• are breastfeeding or plan to breastfeed. It is not known if Entyvio passes into your breast milk.

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

The recommended dosage of Entyvio (vedolizumab) in adults with ulcerative colitis or Crohn's disease is 300 mg administered into a vein (IV) at zero, two and six weeks and then every eight weeks thereafter.

Keep all of your doctors and laboratory appointments.

Call your doctor for instructions if you miss an appointment for your vedolizumab injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel warm or tingly, or if you have a severe headache, fast heart rate, pounding in your neck or ears, chest tightness, or trouble breathing.

Some people using a medicine similar to vedolizumab have developed a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Stop using vedolizumab and call your doctor at once if you have:

• fever, chills, body aches, cold or flu symptoms, mouth and throat ulcers, skin sores;

• pain, warmth, swelling, or oozing around your anal area;

• nausea, vomiting, severe diarrhea, diarrhea that is watery or bloody, stomach cramps, weight loss;

• cough, pain when swallowing; or

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• fever, sore throat, flu symptoms;

• cold symptoms such as stuffy nose, sinus pain, sneezing, cough;

• pain in your arms or legs;

• tired feeling;

• headache, joint pain, back pain;

• rash, itching; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Importance of reviewing the manufacturer's patient information (medication guide).1

• Importance of immediately reporting symptoms consistent with a hypersensitivity reaction (e.g., rash, pruritus, shortness of breath or difficulty breathing, wheezing, dizziness, flushing, palpitations, swelling of lips, tongue, throat, or face) that occur during or following IV infusion of the drug.1

• Increased risk of infection.1 Importance of informing clinician of any signs or symptoms of infection (e.g., fever, chills, cough, dyspnea, fatigue, red or painful skin or sores, myalgia, rhinorrhea, sore throat, pain on urination).1

• Potential for PML to occur in patients who receive a different integrin receptor antagonist.1 Importance of immediately informing clinician of any new or worsening neurologic manifestations (e.g., progressive weakness on one side of body or clumsiness of limbs; changes in speech or walking; vision changes; changes in thinking, memory, and orientation leading to confusion and personality changes).1

• Possibility of increased ALT/AST concentrations, with or without elevated bilirubin concentrations.1 Importance of promptly informing clinician of any symptoms suggestive of hepatic injury (e.g., fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice).1

• Importance of reviewing vaccination status with clinician and receiving all age-appropriate vaccines prior to initiation of vedolizumab therapy.1

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., liver disease, tuberculosis or other infection) or any history of recurrent infections.1

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 (See Pregnancy Under Cautions.)

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

In the U.S.

• Entyvio

Available Dosage Forms:

• Powder for Solution

Pharmacologic Class: Monoclonal Antibody

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Vedolizumab may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, a fever, chills, itching, hives, a rash, dizziness, fainting, lightheadedness, a headache, joint pain, difficulty with swallowing, trouble breathing, or swelling of the face, tongue, and throat.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.

Your body's ability to fight an infection may be reduced with this medicine. Avoid being near people who are sick and wash your hands often. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

This medicine may increase your risk of getting a rare brain infection called progressive multifocal leukoencephalopathy (PML). Call your doctor right away if you have back pain, blurred vision, confusion, dizziness, drowsiness, a fever or headache, seizures, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

While you are being treated with vedolizumab, do not have any immunizations (vaccines) without your doctor's approval. Your vaccinations need to be current before you receive vedolizumab.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Body aches or pain
• chills
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Back pain
• chest tightness
• flushing
• nausea and vomiting
• weakness

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest

• Abdominal or stomach pain
• blurred vision
• clay-colored stools
• confusion
• convulsions
• dark urine
• drowsiness
• headache
• loss of appetite
• lower back or side pain
• painful or difficult urination
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• muscle pain or stiffness
• pain in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Do not receive a "live" vaccine while using Entyvio, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You may receive "killed-virus" vaccines such as a flu shot, polio vaccine, rabies vaccine, or hepatitis A vaccine. Ask your doctor before receiving any vaccine while you are being treated with Entyvio.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have any of these signs of an allergic reaction to Entyvio: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel warm or tingly, or if you have a severe headache, fast heart rate, pounding in your neck or ears, chest tightness, or trouble breathing.

Some people using a medicine similar to Entyvio have developed a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Stop using Entyvio and call your doctor at once if you have:

• fever, chills, body aches, cold or flu symptoms, mouth and throat ulcers, skin sores;

• pain, warmth, swelling, or oozing around your anal area;

• nausea, vomiting, severe diarrhea, diarrhea that is watery or bloody, stomach cramps, weight loss;

• cough, pain when swallowing; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Entyvio side effects may include:

• fever, sore throat, flu symptoms;

• cold symptoms such as stuffy nose, sinus pain, sneezing, cough;

• pain in your arms or legs;

• tired feeling;

• headache, joint pain, back pain;

• rash, itching; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to vedolizumab: intravenous powder for solution

Along with its needed effects, vedolizumab (the active ingredient contained in Entyvio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking vedolizumab:

• Body aches or pain
• chills
• difficulty with breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

• Back pain
• chest tightness
• flushing
• nausea and vomiting
• weakness

• Cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• tightness in the chest

• Abdominal or stomach pain
• blurred vision
• clay-colored stools
• confusion
• convulsions
• dark urine
• drowsiness
• headache
• loss of appetite
• lower back or side pain
• painful or difficult urination
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

Some side effects of vedolizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• muscle pain or stiffness
• pain in the joints

Ulcerative colitis and Crohn's disease: 300 mg IV at zero, two and six weeks and then every eight weeks thereafter.

Comments: Discontinue if no evidence of therapeutic benefit by Week 14.

Uses:
Adult Ulcerative Colitis (UC):
Adults with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. This drug is used for inducing and maintaining clinical response or remission, improving endoscopic appearance of the mucosa, or achieving corticosteroid-free remission.

Adult Crohn's Disease(CD):
Adults with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. This drug is used for achieving clinical response or remission, or achieving corticosteroid-free remission.

Data not available

Administration advice:
-Prior to initiating treatment, bring all patients up to date with all immunizations per current guidelines.
-Administer as an IV infusion over 30 minutes.
-Do not administer as an IV push or bolus.
-After the infusion is complete, flush with 30 mL of sterile 0.9% Sodium Chloride.
-Every four week dosing is not recommended, as it did not demonstrate additional clinical benefit over every 8 week dosing.

Storage requirements:
-Refrigerate; protect from light.
-The infusion solution may be stored for up to four hours at 2C to 8C. Do not freeze.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

IV compatibility: Do not add other medicinal products to the prepared solution or intravenous infusion set.

Patient advice:
-Instruct patients to immediately report hypersensitivity symptoms during or following an infusion.
-Inform patients they may be more likely to develop infections and to report any signs of infection.
-Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred with a different integrin receptor antagonist.
-Instruct patients to immediately report any new onset or worsening of neurological symptoms.
-Inform patients that elevated transaminase levels with or without elevated bilirubin have occurred.
-Instruct patients to report promptly any symptoms of liver injury such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.