BESREMI- ropeginterferon alfa-2b injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

ROPEGINTERFERON ALFA-2B (UNII: 981TME683S) (ROPEGINTERFERON ALFA-2B - UNII:981TME683S)

Dostępny od:

PharmaEssentia USA

Droga podania:

SUBCUTANEOUS

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

BESREMi is indicated for the treatment of adults with polycythemia vera. BESREMi is contraindicated in patients with: - Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt - Hypersensitivity to interferons including interferon alfa-2b or any of the inactive ingredients of BESREMi - Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment - History or presence of active serious or untreated autoimmune disease - Immunosuppressed transplant recipients Risk Summary Available human data with BESREMi use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal studies assessing reproductive toxicity of BESREMi have not been conducted. Based on mechanism of action and the role of interferon alfa in pregnancy and fetal development, BESREMi may cause fetal harm and should be assumed to have abortifacient potential when administered to a pregnant woman. There are adverse effects on maternal and fetal outcomes associated with polycythemia vera in pregnancy (see Clinical Considerations) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population 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 is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Untreated polycythemia vera during pregnancy is associated with adverse maternal outcomes such as thrombosis and hemorrhage. Adverse pregnancy outcomes associated with polycythemia vera include increased risk for miscarriage. There are no data on the presence of BESREMi in human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children from BESREMi, advise women not to breastfeed during treatment and for 8 weeks after the final dose. BESREMi may cause embryo-fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)] . Pregnancy Testing Pregnancy testing prior to BESREMi treatment is recommended for females of reproductive potential. Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with BESREMi and for at least 8 weeks after the final dose. Infertility Females Based on its mechanism of action, BESREMi can cause disruption of the menstrual cycle [see Clinical Pharmacology (12.1)] . No animal fertility studies have been conducted with BESREMi. Safety and effectiveness in pediatric patients have not been established. Clinical studies of BESREMi did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other therapy. No dose adjustment is necessary in patients with estimated glomerular filtration rate (eGFR) ≥30 mL/min [see Clinical Pharmacology (12.3)]. Avoid use of BESREMi in patients with eGFR <30 mL/min [see Warnings and Precautions (5.12)]. BESREMi is contraindicated in patients with hepatic impairment (Child-Pugh B or C) [see Contraindications (4)] . Increased liver enzyme levels have been observed in patients treated with BESREMi. When the increase in liver enzyme levels is progressive and persistent, reduce the dose of BESREMi. If the increase in liver enzymes is progressive and clinically significant despite dose-reduction, or if there is evidence of hepatic impairment (Child-Pugh B or C), discontinue BESREMi [see Dosage and Administration (2.2) and Warnings and Precautions (5.11)] . - Keep your BESREMi prefilled syringes in their original carton (Figure B) while stored. - Do not freeze the prefilled syringes. - Do not use a prefilled syringe that has been frozen or left in direct sunlight. - Keep BESREMi prefilled syringes, needles, and all medicines out of the reach of children. - Your healthcare provider will tell you the prescribed dose that you should take and the right amount of BESREMi to measure in the prefilled syringe for your dose. Each time you inject, be sure that you know the prescribed dose of BESREMi to inject. Your dose may change over time. - BESREMi is for subcutaneous (under the skin) injection only. - BESREMi is for one-time use only. Do not reuse your prefilled syringe or needle. - Do not use a prefilled syringe or needle that is damaged or broken. Contact your healthcare provider for a replacement prefilled syringe or additional needles. - Inject BESREMi into the top of the thighs or lower stomach-area just under the skin. Do not inject BESREMi into any other area of the body. - Throw away (dispose of) the BESREMi prefilled syringe with needle attached right away after use, even if there is medicine left in the prefilled syringe. See Step 10 in the section " Dispose of used prefilled syringes and needles." - Lower stomach (abdomen) area, at least 2 inches away from the belly button, - Top of thighs. Do not inject into skin that is irritated, red, bruised, infected, or scarred. BESREMi is for subcutaneous (under the skin) injection only. Rotate (change) the injection site for each injection. - Hold the prefilled syringe at eye level with the needle pointing straight up over a paper towel, sink, or trash can. - Check that you can see the dose lines and number markings on the prefilled syringe. - Pinch the end of the plunger as shown (Figure Z). - Slowly push up on the plunger to remove liquid medicine until the top edge of the gray stopper lines up with the marking for your prescribed dose (Figure Z). Keep holding straight up as you set the dose. Important: If you accidentally remove too much liquid medicine, do not inject. Contact your healthcare provider or pharmacist. - Put your used prefilled syringes and needles in a FDA-cleared sharps disposal container right away after use (Figure AF). Do not throw away (dispose of) loose prefilled syringes and needles in the household trash. - If you do not have a FDA-cleared sharps disposal container, you may use a household container that is: made of a 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. - made of a 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 state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. - Do not dispose of your sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container. - Always keep the sharps disposal container out of the reach of children.

Podsumowanie produktu:

BESREMi (ropeginterferon alfa-2b-njft) injection is a sterile, preservative-free, clear and colorless to slightly yellowish solution for subcutaneous administration in a single-dose prefilled syringe. Each carton contains one 500 mcg/mL prefilled syringe with a 30 gauge, ½ inch safety hypodermic needle (NDC 73536-500-01). Store in a refrigerator at 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light. Do not freeze.

Status autoryzacji:

Biologic Licensing Application

Ulotka dla pacjenta

PharmaEssentia USA
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MEDICATION GUIDE
BESREMI ® (BEZ-REH-ME)
ROPEGINTERFERON ALFA-2B-NJFT
INJECTION, FOR SUBCUTANEOUS USE
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Issued: 11/2021
What is the most important information I should know about BESREMi?
BESREMi can cause serious side effects that:
•
may cause death, or
•
may worsen certain serious diseases that you may already have
Tell your healthcare provider right away if you have any of the
symptoms listed below during treatment
with BESREMi. If symptoms get worse, or become severe and continue,
your healthcare provider may
tell you to stop taking BESREMi permanently. These symptoms may go
away in some people after they
stop taking BESREMi. Mental health problems, including suicide.
BESREMi may cause you to develop
mood or behavior problems that may get worse during treatment with
BESREMi or after your last dose,
including:
•
irritability (getting upset easily)
•
restlessness and agitation
•
confusion
•
depression (feeling low, feeling bad about yourself or feeling
hopeless)
•
unusually grand ideas
•
acting aggressive
•
acting impulsively
•
thoughts of hurting yourself or others, or thoughts of suicide
If you develop any of these symptoms, stop using BESREMi right away.
You, your caregiver, or family
member should call your healthcare provider right away. Your
healthcare provider should carefully
monitor you during treatment with BESREMi.
New or worsening autoimmune problems. BESREMi may cause autoimmune
problems (a condition
where the body's immune cells attack other cells or organs in the
body), including thyroid problems,
increased blood sugar (hyperglycemia), and type I diabetes. In some
people who already have an
autoimmune problem, it may get worse during your treatment with
BESREMi. Tell your healthcare
provider if you have any of the following symptoms: tiredness,
urinating often, or if you are very thirsty.
Heart problems. BESREMI may cause heart problems, including problems
with your he

Charakterystyka produktu

BESREMI- ROPEGINTERFERON ALFA-2B INJECTION
PHARMAESSENTIA USA
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BESREMI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BESREMI. BESREMI
(ROPEGINTERFERON ALFA-2B-
NJFT) INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2021
WARNING: RISK OF SERIOUS DISORDERS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
RISK OF SERIOUS DISORDERS: INTERFERON ALFA PRODUCTS MAY CAUSE OR
AGGRAVATE FATAL OR
LIFE-THREATENING NEUROPSYCHIATRIC, AUTOIMMUNE, ISCHEMIC, AND
INFECTIOUS DISORDERS.
MONITOR CLOSELY AND WITHDRAW THERAPY WITH PERSISTENTLY SEVERE OR
WORSENING SIGNS OR
SYMPTOMS OF THE ABOVE DISORDERS.
INDICATIONS AND USAGE
BESREMi is an interferon alfa-2b indicated for the treatment of adults
with polycythemia vera ( 1)
DOSAGE AND ADMINISTRATION
Recommended starting dose: 100 mcg by subcutaneous injection every 2
weeks (50 mcg if receiving
hydroxyurea).
Increase the dose by 50 mcg every 2 weeks (up to a maximum of 500 mcg)
until hematological
parameters are stabilized ( 2.1)
Interrupt or discontinue dosing if certain adverse reactions occur (
2.3, 5)
DOSAGE FORMS AND STRENGTHS
Injection: 500 mcg/mL solution in a single-dose prefilled syringe ( 3)
CONTRAINDICATIONS
Existence of, or history of severe psychiatric disorders, particularly
severe depression, suicidal ideation
or suicide attempt ( 4)
Hypersensitivity to interferon or to any component of BESREMi ( 4)
Hepatic impairment (Child-Pugh B or C) ( 4)
History or presence of active serious or untreated autoimmune disease
( 4)
Immunosuppressed transplant recipients ( 4)
WARNINGS AND PRECAUTIONS
Patients exhibiting the following events should be closely monitored
and may require dose reduction or
discontinuation of therapy:
Depression and Suicide: Monitor closely for symptoms and need for
treatment. ( 5.1)
Endocrine Toxicity: Discontinue if endocrine disorders occur that
cannot be medically managed. ( 5.2)
Cardiovascular Toxicity: Avoid us