KRYSTEXXA- pegloticase injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PEGLOTICASE (UNII: R581OT55EA) (PEGLOTICASE - UNII:R581OT55EA)

Available from:

Horizon Therapeutics USA, Inc.

INN (International Name):

PEGLOTICASE

Composition:

PEGLOTICASE 8 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KRYSTEXXA® (pegloticase) is indicated, for the treatment of chronic gout in adult patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated. Limitations of Use: KRYSTEXXA is not recommended for the treatment of asymptomatic hyperuricemia. KRYSTEXXA is contraindicated in: - Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency [see Warnings and Precautions (5.3)] - Patients with history of serious hypersensitivity reactions, including anaphylaxis, to KRYSTEXXA or any of its components Risk Summary There are no adequate and well-controlled studies of KRYSTEXXA in pregnant women. Based on animal reproduction studies, no structural abnormalities were observed when pegloticase was administered by subcutaneous injection to pregnant rats and

Product summary:

How Supplied KRYSTEXXA (pegloticase) injection is supplied as a sterile, clear and colorless solution containing 8 mg of uricase protein in 1 mL in phosphate buffered saline intended for intravenous infusion after dilution. KRYSTEXXA is supplied in a single-dose glass vial with a coated (latex-free) rubber injection stopper. Storage and Handling Before the preparation for use, KRYSTEXXA must be stored in the carton and maintained at all times under refrigeration between 2°C to 8°C (36°F to 46°F). Protect from light. Do not shake or freeze. Do not use beyond the expiration date stamped. NDC# 75987-080-10

Authorization status:

Biologic Licensing Application

Patient Information leaflet

KRYSTEXXA- PEGLOTICASE INJECTION, SOLUTION
Horizon Therapeutics USA, Inc.
----------
MEDICATION GUIDE
KRYSTEXXA® (KRIS-TEX-A)
(PEGLOTICASE)
INJECTION, FOR INTRAVENOUS USE
Read this Medication Guide before you start receiving KRYSTEXXA and
before each treatment. There may
be new information. This Medication Guide does not take the place of
talking with your doctor about your
medical condition or treatment. Talk to your doctor if you have any
questions about your treatment with
KRYSTEXXA.
What is the most important information I should know about KRYSTEXXA?
Serious allergic reactions may happen in some people who receive
KRYSTEXXA. These allergic reactions
can be life threatening and usually happen within 2 hours of the
infusion.
KRYSTEXXA should be given to you by a doctor or nurse in a healthcare
setting where serious allergic
reactions can be treated. Your doctor or nurse should watch you for
any signs of a serious allergic reaction
during and after your treatment with KRYSTEXXA.
Tell your doctor or nurse right away if you have any of these symptoms
during or after your treatment with
KRYSTEXXA:
•
wheezing, shortness of breath, cough, chest tightness, chest pain, or
trouble breathing
•
dizziness, fainting, fast or weak heartbeat or feeling nervous
•
reddening of the face, itching, hives, or feeling warm
•
swelling of the throat or tongue, throat tightness, hoarse voice or
trouble swallowing
What is KRYSTEXXA?
•
KRYSTEXXA is a prescription medicine used in adults to help reduce the
signs and symptoms of
gout that are not controlled by other treatments.
•
People with gout have too much uric acid in their bodies. Uric acid
crystals collect in joints, kidneys,
and other organs. This may cause pain, redness and swelling
(inflammation). KRYSTEXXA works to
lower blood levels of uric acid.
•
KRYSTEXXA is not for use in people with too much uric acid in their
bodies who do not have
symptoms (asymptomatic hyperuricemia).
It is not known if KRYSTEXXA is safe and effective in children under
18 years of age.
W

Summary of Product characteristics

KRYSTEXXA- PEGLOTICASE INJECTION, SOLUTION
HORIZON THERAPEUTICS USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KRYSTEXXA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KRYSTEXXA
KRYSTEXXA (PEGLOTICASE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2010
WARNING: ANAPHYLAXIS AND INFUSION REACTIONS, G6PD DEFICIENCY
ASSOCIATED
HEMOLYSIS AND METHEMOGLOBINEMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANAPHYLAXIS AND INFUSION REACTIONS HAVE BEEN REPORTED TO OCCUR DURING
AND AFTER
ADMINISTRATION OF KRYSTEXXA. (5.1, 5.2)
ANAPHYLAXIS MAY OCCUR WITH ANY INFUSION, INCLUDING A FIRST INFUSION,
AND GENERALLY
MANIFEST WITHIN 2 HOURS OF THE INFUSION. HOWEVER, DELAYED
HYPERSENSITIVITY REACTIONS
HAVE ALSO BEEN REPORTED. (5.1)
KRYSTEXXA SHOULD BE ADMINISTERED IN HEALTHCARE SETTINGS AND BY
HEALTHCARE
PROVIDERS PREPARED TO MANAGE ANAPHYLAXIS AND INFUSION REACTIONS. (5.1,
5.2)
PRE-MEDICATE WITH ANTIHISTAMINES AND CORTICOSTEROIDS AND CLOSELY
MONITOR FOR
ANAPHYLAXIS FOR AN APPROPRIATE PERIOD OF TIME AFTER ADMINISTRATION OF
KRYSTEXXA.
(5.1, 5.2)
MONITOR SERUM URIC ACID LEVELS PRIOR TO EACH INFUSION AND DISCONTINUE
TREATMENT IF
LEVELS INCREASE TO ABOVE 6 MG/DL, PARTICULARLY WHEN 2 CONSECUTIVE
LEVELS ABOVE 6
MG/DL ARE OBSERVED. (5.2)
SCREEN PATIENTS AT RISK FOR G6PD DEFICIENCY PRIOR TO STARTING
KRYSTEXXA. HEMOLYSIS
AND METHEMOGLOBINEMIA HAVE BEEN REPORTED WITH KRYSTEXXA IN PATIENTS
WITH G6PD
DEFICIENCY. KRYSTEXXA IS CONTRAINDICATED IN PATIENTS WITH G6PD
DEFICIENCY. (4, 5.3)
RECENT MAJOR CHANGES
Dosage and Administration, Dosage (2.1)
7/2022
Contraindications (4)
7/2022
Warnings and Precautions (5.1, 5.2)
7/2022
INDICATIONS AND USAGE
KRYSTEXXA (pegloticase) is a PEGylated uric acid specific enzyme
indicated for the treatment of chronic
gout in adult patients refractory to conventional therapy.(1)
Limitations of Use:
KRYSTEXXA is not recommended for the treatment of asymptomatic
hyperuricemia. (1)
DOSAGE AND ADMINISTRATION