ENTYVIO- vedolizumab injection, powder, lyophilized, for solution ENTYVIO PEN- vedolizumab injection, solution ENTYVIO- vedolizumab injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

VEDOLIZUMAB (UNII: 9RV78Q2002) (VEDOLIZUMAB - UNII:9RV78Q2002)

可用日期:

Takeda Pharmaceuticals America, Inc.

INN（国际名称）:

VEDOLIZUMAB

组成:

VEDOLIZUMAB 300 mg in 5 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

ENTYVIO is indicated in adults for the treatment of: - moderately to severely active ulcerative colitis (UC). - moderately to severely active Crohn's disease (CD). ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate) [see Warnings and Precautions (5.1)] . Risk Summary Available data from the Organization of Teratology Information Specialists (OTIS)/MotherToBaby ENTYVIO Pregnancy Registry, published literature and pharmacovigilance in pregnant women have not reliably identified an ENTYVIO-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data) . There are risks to the mother and the fetus associated with inflammatory bowel disease in pregnancy (see Clinical Considerations) . No fetal harm was observed in animal reproduction studies with intravenous administration of vedolizumab to rabbits and monkeys at dose levels 20 times the recommended human dosage (see Data) . The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and miscarriage is 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and Embryo/Fetal Risk Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease (IBD) is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth. Fetal/Neonatal Adverse Reactions ENTYVIO administered during pregnancy could affect immune responses in the in utero exposed newborn and infant. The clinical significance of low levels of ENTYVIO in utero-exposed infants is unknown. The safety of administering live or live-attenuated vaccines in exposed infants is unknown. Data Human Data The vedolizumab pregnancy exposure registry conducted by OTIS/MotherToBaby study in the United States and Canada collected prospective observational data between 2015 and 2022 to assess the risk of major birth defects in live-born infants of women with ulcerative colitis (UC) or Crohn’s disease (CD) treated with vedolizumab during pregnancy. The study compared pregnant patients with UC or CD exposed to vedolizumab with pregnant patients with UC or CD treated with other biological products. The registry included 99 women (58 with UC, 41 with CD) treated with vedolizumab during pregnancy, and 76 women (27 with UC, 49 with CD) exposed to other biological products during pregnancy. The proportion of major birth defects among live-born infants in patients with UC or CD treated with vedolizumab and patients with UC or CD treated with other biological products was 7.4% (7/94) and 5.6% (4/71), respectively. Overall, there was no evidence of increased risk for major structural birth defects (adjusted RR 1.07, 95% CI: 0.33, 3.52). The methodological limitations of the registry, including small sample size and the non-randomized design, resulted in a limited ability to estimate the risk of major birth defects and other maternal and infant outcomes. The conclusions from the pregnancy registry were consistent with the published literature and pharmacovigilance. Animal Data A reproduction study has been performed in pregnant rabbits at single intravenous doses up to 100 mg/kg administered on gestation Day 7 (about 20 times the recommended human dosage) and has revealed no evidence of impaired fertility or harm to the fetus due to vedolizumab. A pre- and post-natal development study in monkeys showed no evidence of any adverse effect on pre- and post-natal development at intravenous doses up to 100 mg/kg (about 20 times the recommended human dosage). Risk Summary Data from a clinical lactation study show the presence of vedolizumab in human milk. The mean calculated daily infant dosage was 0.02 mg/kg/day orally (see Data) . Systemic exposure in a breastfed infant is expected to be low because monoclonal antibodies are largely degraded in the gastrointestinal tract. There are no data on the effects of vedolizumab on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ENTYVIO and any potential adverse effects on the breastfed infant from ENTYVIO or from the underlying maternal condition. Data A milk-only lactation study was conducted in 9 adult lactating women being treated for active ulcerative colitis or Crohn's disease with intravenous ENTYVIO every 8 weeks after reaching steady state and completing the induction phase (ENTYVIO administration at 0, 2, and 6 weeks). Mean concentrations of ENTYVIO in human milk ranged from 0.03 to 0.26 mcg/mL. The mean calculated daily infant oral dosage was 0.02 mg/kg/day calculated as a product of the average concentration over the 8-week dosing interval and the standardized milk consumption of 150 mL/kg/day. Safety and effectiveness of ENTYVIO in pediatric patients have not been established. Clinical trials of ENTYVIO did not include sufficient numbers of subjects aged 65 and over (56 Crohn's and ulcerative colitis patients aged 65 and over were treated with ENTYVIO during controlled Phase 3 trials) to determine whether they respond differently from younger subjects. However, no overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. ENTYVIO ® (en ti' vee oh) PEN (vedolizumab) injection, for subcutaneous use Single-dose prefilled pen This Instructions for Use contains information on how to inject ENTYVIO. Your ENTYVIO single-dose prefilled pen - Read and follow this Instructions for Use before you inject ENTYVIO. - Your healthcare provider should show you how to use the ENTYVIO PEN before you use it for the first time. - ENTYVIO PEN is for subcutaneous injection only (inject directly into fatty layer under the skin). - Do not shake the prefilled pen. - Do not remove the purple cap from the prefilled pen until you are ready to inject. - Do not put or press your thumb, fingers, or hand over the yellow needle shield. The yellow needle shield is visible when the purple cap is removed. - Do not use the prefilled pen if it is dropped or damaged. Storing ENTYVIO - Store your prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C). - Your prefilled pen can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling). Do not use the prefilled pen if it is left out of the refrigerator for more than 7 days. - Do not freeze the prefilled pen. - Do not leave the prefilled pen in direct sunlight. - Throw away the prefilled pen in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. See Step 14 for instructions on how to throw away (dispose of) the prefilled pen. - Always keep ENTYVIO PENs, the sharps disposal container, and all medicines out of the reach of children. - Do not use the prefilled pen if any of the seals on the box are broken. - Do not use the prefilled pen if the expiration date on the box has passed. - Do not warm the prefilled pen any other way. - Do not let the prefilled pen sit in direct sunlight. - Do not take the prefilled pen out of its tray until you are ready to inject. - Alcohol pad - Cotton ball or gauze - Sharps disposal container (see Step 14 "Throw away (dispose of) the prefilled pen") - Do not shake the prefilled pen. - Do not remove the purple cap from the prefilled pen until Step 9 . - Do not use the prefilled pen if the expiration date on the prefilled pen has passed. - Do not use the prefilled pen if the medicine is cloudy or has particles floating in it. - Do not use the prefilled pen if any part of it is damaged. - Do not inject into the same spot you used for your last injection. - Do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged. - Do not touch or blow on the cleaned injection site before you inject. - The needle is inside the yellow needle shield (under purple cap). - Do not put or press your thumb, fingers, or hand over the yellow needle shield. - Do not put the purple cap back on. This could accidentally start the injection. - Hold the prefilled pen so you can see the viewing window. - Place the yellow end of the prefilled pen flat on your skin at 90 degrees to the injection site (see Figure J ). - The needle is inside the yellow needle shield. - Do not push down on the prefilled pen until you are ready to inject. - You may hear a first click when the injection starts. - You may hear a second click. This is not the end of the injection. - Continue holding the prefilled pen with constant pressure and watch the window turn purple. - You will see a small amount of gray in the viewing window. This is normal. - If the viewing window did not fill with purple, you may not have received your full dose. Call your pharmacy or healthcare provider. - When you remove the prefilled pen, if the window has not turned purple, or it looks like the medicine is still coming out of the prefilled pen, this means you have not received a full dose. Call your pharmacy or healthcare provider right away. - You may see a small amount of blood at the injection site. If you do, press on your skin with a cotton ball or gauze. - Throw away the remaining supplies in your household trash or sharps disposal container. - If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local or state laws about how you should throw away needles and syringes. - For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 9/2023 ENTYVIO® (en ti' vee oh) (vedolizumab) injection, for subcutaneous use Single-dose prefilled syringe This Instructions for Use contains information on how to inject ENTYVIO. Your ENTYVIO single-dose prefilled syringe - Read and follow this Instructions for Use before you inject ENTYVIO. - Your healthcare provider should show you how to use the ENTYVIO prefilled syringe before you use it for the first time. - ENTYVIO prefilled syringe is for subcutaneous injection only (inject directly into fatty layer under the skin). - Do not shake the prefilled syringe. - Do not remove the needle cap from the prefilled syringe until you are ready to inject. - Do not use the prefilled syringe if it is dropped or damaged. - Each prefilled syringe has a needle guard. It will automatically cover the needle after the injection is completed to reduce the risk of accidental needle sticks. Storing ENTYVIO - Store your prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C). - Your prefilled syringe can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling). Do not use the prefilled syringe if it is left out of the refrigerator for more than 7 days. - Do not freeze the prefilled syringe. - Do not leave the prefilled syringe in direct sunlight. - Throw away the prefilled syringe in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight. See Step 14 for instructions on how to throw away (dispose of) the prefilled syringe. - Always keep ENTYVIO prefilled syringes, the sharps disposal container, and all medicines out of the reach of children. - Do not use the prefilled syringe if any of the seals on the box are broken. - Do not use the prefilled syringe if the expiration date on the box has passed. - Do not warm the prefilled syringe any other way. - Do not let the prefilled syringe sit in direct sunlight. - Do not take the prefilled syringe out of its tray until you are ready to inject. - Alcohol pad - Cotton ball or gauze - Sharps disposal container (see Step 14 "Throw away (dispose of) the prefilled syringe") - Do not lift from the purple plunger. - Do not shake the prefilled syringe. - Do not remove the needle cap from the prefilled syringe until Step 9 . - Do not use the prefilled syringe if the expiration date on the prefilled syringe has passed. - Do not use the prefilled syringe if the medicine is cloudy or has particles floating in it. - Do not use the prefilled syringe if any part of it is damaged. - Do not try to remove air bubbles from the prefilled syringe. - Do not inject into the same spot you used for your last injection. - Do not inject into moles, scars, bruises, or skin that is tender, hard, red, or damaged. - Do not touch or blow on the cleaned injection site before you inject. - Do not touch or pull back the purple plunger. - Do not touch or re-cap the needle. - Do not use a prefilled syringe with a bent or broken needle. - Hold the pinch until the injection is completed. - Avoid touching the plunger until the needle is inserted. - Keep pressure on the plunger and take the needle out of the skin. - If you are not able to start or cannot complete the injection by pushing the plunger all the way down, you may not have received your full dose. Call your pharmacy or healthcare provider. - You may see a small amount of blood at the injection site. If you do, press on your skin with a cotton ball or gauze. - Throw away the remaining supplies in your household trash or sharps disposal container. - If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: - made of heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be local or state laws about how you should throw away needles and syringes. - For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Approved: 9/2023

產品總結:

How Supplied Intravenous Infusion ENTYVIO® (vedolizumab) for injection for intravenous infusion is supplied in sterile single-dose glass vials, containing 300 mg of vedolizumab as a white to off-white lyophilized cake. Subcutaneous Injection ENTYVIO (vedolizumab) injection for subcutaneous use is available in a prefilled syringe or a prefilled pen as a clear to moderately opalescent and colorless to slightly yellow solution. The single-dose, disposable ENTYVIO prefilled syringe and single-dose, disposable ENTYVIO prefilled pen (ENTYVIO PEN) are comprised of a 1 mL long glass syringe with a fixed 27 gauge thin wall, ½ inch needle. The syringe has a rubber needle cover encased in a plastic shell and rubber stopper. Not made with natural rubber latex. Storage and Handling

授权状态:

Biologic Licensing Application

资料单张

ENTYVIO PEN- VEDOLIZUMAB INJECTION, SOLUTION
ENTYVIO- VEDOLIZUMAB INJECTION, SOLUTION
Takeda Pharmaceuticals America, Inc.
----------
MEDICATION GUIDE
ENTYVIO® (EN TI' VEE OH)
(VEDOLIZUMAB)
FOR INJECTION, FOR
INTRAVENOUS USE
ENTYVIO® (EN TI' VEE OH)
(VEDOLIZUMAB)
INJECTION, FOR SUBCUTANEOUS
USE
ENTYVIO® (EN TI' VEE OH) PEN
(VEDOLIZUMAB)
INJECTION, FOR SUBCUTANEOUS USE
This Medication Guide has been approved by the U.S.
Food and Drug Administration
VMB245 R10 Revised: 2/2024
What is the most important information I should know about ENTYVIO?
ENTYVIO may cause serious side effects, including:
•
Infusion-related and serious allergic reactions. These reactions can
happen while you are
receiving ENTYVIO or several hours after treatment. You may need
treatment if you have an
allergic reaction. Tell your healthcare provider or get medical help
right away if you get any of
these symptoms during or after an infusion of ENTYVIO: rash, itching,
swelling of your lips,
tongue, throat or face, shortness of breath or trouble breathing,
wheezing, dizziness, feeling hot,
or palpitations (feel like your heart is racing).
•
Infections. ENTYVIO may increase your risk of getting a serious
infection. Before receiving
ENTYVIO and during treatment with ENTYVIO, tell your healthcare
provider if you think you
have an infection or have symptoms of an infection such as fever,
chills, muscle aches, cough,
shortness of breath, runny nose, sore throat, red or painful skin or
sores on your body, tiredness,
or pain during urination.
•
Progressive Multifocal Leukoencephalopathy (PML). People with weakened
immune systems can
get progressive multifocal leukoencephalopathy (PML) (a rare, serious
brain infection caused by
a virus). Although unlikely while receiving ENTYVIO, a risk of PML
cannot be ruled out. PML
can result in death or severe disability. There is no known treatment,
prevention, or cure for PML.
Tell your healthcare provider right away if you have any of the
following symptoms: confusion or
problems thinking, loss of balance,

产品特点

ENTYVIO- VEDOLIZUMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ENTYVIO PEN- VEDOLIZUMAB INJECTION, SOLUTION
ENTYVIO- VEDOLIZUMAB INJECTION, SOLUTION
TAKEDA PHARMACEUTICALS AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENTYVIO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENTYVIO.
ENTYVIO (VEDOLIZUMAB) FOR INJECTION, FOR INTRAVENOUS USE
ENTYVIO (VEDOLIZUMAB) INJECTION, FOR SUBCUTANEOUS USE
ENTYVIO PEN (VEDOLIZUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Dosage and Administration
Important Administration Information (2.1)
9/2023
Recommended Dosage in Adults with Ulcerative Colitis (2.2)
9/2023
INDICATIONS AND USAGE
ENTYVIO is an integrin receptor antagonist indicated in adults for the
treatment of:
moderately to severely active ulcerative colitis (UC). (1)
moderately to severely active Crohn's disease (CD). (1)
DOSAGE AND ADMINISTRATION
Important Administration Information
Before initiating ENTYVIO, update immunizations according to current
immunization guidelines. (2.1,
5.5)
_Intravenous Administration_: ENTYVIO should be administered
intravenously by a healthcare provider.
(2.1)
_Subcutaneous Injection_: ENTYVIO prefilled syringe and ENTYVIO PEN
are intended for subcutaneous use.
A patient may self-inject or caregiver may inject after proper
training on correct subcutaneous injection
technique. (2.1)
Recommended Dosage
Recommended intravenous dosage in UC and CD: 300 mg infused
intravenously over approximately 30
minutes at Week 0, Week 2, Week 6, then every eight weeks thereafter.
(2.2, 2.3)
Following the first two ENTYVIO intravenous doses administered at Week
0 and Week 2 in UC, ENTYVIO
may be switched to subcutaneous injection at Week 6. Recommended
subcutaneous dosage in UC
starting at Week 6: 108 mg administered every 2 weeks. (2.2)
ENTYVIO may be switched from intravenous infusion to subcutaneous
injection, for patients in clinical
response or remission beyond Week