ASTAGRAF XL- tacrolimus extended-release capsules capsule, coated, extended release

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)

Dostopno od:

Astellas Pharma US, Inc.

INN (mednarodno ime):

TACROLIMUS

Sestava:

TACROLIMUS ANHYDROUS 0.5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

ASTAGRAF XL® is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact [see Use in Specific Populations (8.4) and Clinical Studies (14.1), (14.2)]. ASTAGRAF XL is contraindicated in patients with known hypersensitivity to tacrolimus [see Adverse Reactions (6.2)] . Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to ASTAGRAF XL during pregnancy. The Transplantation Pregnancy Registry International (TPRI) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. Healthcare providers are encouraged to advise their patients to register by contacting the Transplantation Pregnancy Registry International at 1-877-955-6877 or https://www.transplantpregnancyregistry.org/. Risk

Povzetek izdelek:

ASTAGRAF XL (tacrolimus) extended-release capsules are supplied in short, square bottles (see Table 19). 0.5 mg Oblong capsule with a light yellow cap and orange body. Capsule is branded with red “ 1 mg Oblong capsule with a white cap and orange body. Capsule is branded with red “ 5 mg Oblong capsule with a grayish-red cap and orange body. Capsule is branded with red “ Store and Dispense Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Status dovoljenje:

New Drug Application

Navodilo za uporabo

Astellas Pharma US, Inc.
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MEDICATION GUIDE
ASTAGRAF XL® [as' tah graf ex el']
(tacrolimus)
extended-release capsules
Read this Medication Guide before you start taking ASTAGRAF XL 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 your treatment. If you have
any questions about ASTAGRAF
XL, ask your healthcare provider or pharmacist.
What is the most important information I should know about ASTAGRAF
XL?
ASTAGRAF XL can cause serious side effects, including:
•
Increased risk of cancer. People who take ASTAGRAF XL have an
increased risk of getting some
kinds of cancer, including skin and lymph gland cancer (lymphoma).
•
Increased risk of infection. ASTAGRAF XL is a medicine that affects
your immune system.
ASTAGRAF XL can lower the ability of your immune system to fight
infections. Serious
infections can happen in people receiving ASTAGRAF XL that can cause
death. Call your
healthcare provider right away if you have symptoms of an infection
such as:
•
fever
•
sweats or chills
•
cough or flu-like symptoms
•
muscle aches
•
warm, red, or painful
areas on your skin
•
Increased risk of death in females who have had a liver transplant.
You should not take
ASTAGRAF XL if you have had a liver transplant without talking to your
healthcare provider.
What is ASTAGRAF XL?
•
ASTAGRAF XL is a prescription medicine used with other medicines to
help prevent organ
rejection in people who have had a kidney transplant.
•
ASTAGRAF XL is an extended-release capsule and is not the same as
tacrolimus immediate-
release capsules, tacrolimus for oral suspension or tacrolimus
extended-release tablets. Your
healthcare provider should decide what medicine is right for you.
Who should not take ASTAGRAF XL?
•
Do not take ASTAGRAF XL if you are allergic to tacrolimus or any of
the ingredients in
ASTAGRAF XL. See the end of this leaflet for a complete list of
ingredients in ASTAGRAF XL.
Wha

Lastnosti izdelka

ASTAGRAF XL- TACROLIMUS EXTENDED-RELEASE CAPSULES CAPSULE, COATED,
EXTENDED RELEASE
ASTELLAS PHARMA US, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ASTAGRAF XL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASTAGRAF XL.
ASTAGRAF XL (TACROLIMUS EXTENDED-RELEASE CAPSULES), FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: MALIGNANCIES AND SERIOUS INFECTIONS IN TRANSPLANT PATIENTS;
AND
INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
RECENT MAJOR CHANGES
Warnings and Precautions (5.6, 5.14) 11/2022
Warnings and Precautions, Cannabidiol Drug Interactions (5.15) 08/2023
INDICATIONS AND USAGE
ASTAGRAF XL is a calcineurin-inhibitor immunosuppressant indicated for
the prophylaxis of organ rejection
in kidney transplant patients in combination with other
immunosuppressants in adult and pediatric
patients who can swallow capsules intact. (1, 8.4, 14.1, 14.2)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
RECOMMENDED ASTAGRAF XL INITIAL DOSAGE
Patient Population
Initial Oral Dosage
Whole Blood Trough Concentration Range
ADULT
With basiliximab, MMF
and steroids
0.15 to 0.2 mg/kg once daily prior to
reperfusion or within 48 hours of
completion of transplant
•
•
•
With MMF and steroids,
without basiliximab
induction
•
•
•
•
•
®
INCREASED RISK FOR DEVELOPING SERIOUS INFECTIONS AND MALIGNANCIES WITH
ASTAGRAF
XL OR OTHER IMMUNOSUPPRESSANTS THAT MAY LEAD TO HOSPITALIZATION OR
DEATH. (5.1,
5.2)
INCREASED MORTALITY IN FEMALE LIVER TRANSPLANT PATIENTS WITH ASTAGRAF
XL. NOT
APPROVED FOR USE IN LIVER TRANSPLANTATION. (5.3)
Capsules must be taken whole. (2.1)
Take consistently every morning at the same time on an empty stomach
at least 1 hour before a
meal or at least 2 hours after a meal. (2.1)
Avoid eating grapefruit or drinking grapefruit juice or alcohol. (2.1)
African-American patients and patients with severe hepatic impairment
may require dosing