Approved Drug Label (PDF)
5
Warnings and Precautions
5.8 Pulmonary Arterial Hypertension
(Newly added subsection)
Cases of pulmonary arterial hypertension
(PAH) have been reported with interferon beta products, including BETASERON.
PAH has occurred in patients treated with interferon beta products in the
absence of other contributory factors. Many of the reported
cases required hospitalization, including one case with interferon beta in which the patient underwent a lung transplant. PAH
has developed at various time points after initiating therapy with interferon
beta products and may occur several years after starting treatment.
Patients
who develop unexplained symptoms (e.g., dyspnea,
new or increasing fatigue) should
be assessed for PAH. If alternative etiologies have been ruled
out and a diagnosis of PAH is confirmed, discontinue treatment and manage as
clinically indicated.
6
Adverse Reactions
(Additions and/or revisions
underlined)
The following
serious adverse reactions are discussed in more details
in other sections
of labeling:
·
Hepatic Injury [see Warnings
and Precautions (5.1)]
·
Anaphylaxis and Other Allergic
Reactions [see Warnings
and Precautions (5.2)]
·
Depression and Suicide [see
Warnings and Precautions (5.3)]
·
Congestive Heart Failure [see
Warnings and Precautions (5.4)]
·
Injection Site Reactions Including
Necrosis [see Warnings
and Precautions (5.5)]
·
Leukopenia [see
Warnings and Precautions (5.6)]
·
Thrombotic Microangiopathy [see Warnings and Precautions (5.7)]
· Pulmonary Arterial Hypertension [see
Warnings and Precautions (5.8)]
· Flu-like
Symptom Complex [see
Warnings and Precautions (5.9)]
· Seizures
[see Warnings and Precautions (5.10)]
· Drug Induced Lupus Erythematosus [see
Warnings and Precautions (5.11)]
6.3 Postmarketing Experience
(Additions
and/or revisions underlined)
The following adverse
reactions have been identified during
postapproval use of BETASERON. Because
these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.
Blood and lymphatic system disorders: Anemia, Thrombocytopenia, Hemolytic anemia
Endocrine disorders: Hypothyroidism, Hyperthyroidism, Thyroid dysfunction
Metabolism and nutrition disorders: Triglyceride increased, Anorexia, Weight decrease, Weight increase
Psychiatric disorders: Anxiety,
Confusion, Emotional lability
Nervous
system disorders: Convulsion, Dizziness, Psychotic Symptoms
Cardiac disorders: Cardiomyopathy, Palpitations, Tachycardia
Vascular disorders: Vasodilatation
Respiratory, thoracic and mediastinal disorders: Bronchospasm, Pulmonary Arterial Hypertension
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions underlined)
See FDA-approved patient
labeling (Medication Guide and Instructions for Use).
Instruct
patients to carefully
read the supplied
BETASERON Medication Guide and caution
patients not to change the BETASERON dose or schedule of
administration without medical consultation.
Instruction on Self-Injection Technique
and Procedures
Provide
appropriate instruction for reconstitution of BETASERON and methods of self-injection, including careful review of
the BETASERON Medication Guide. Instruct
patients in the use of aseptic technique when administering BETASERON.
Tell patients not to re-use needles or syringes and instruct patients
on safe disposal procedures. Advise
patients of the importance of rotating areas of
injection with each dose, to minimize the likelihood of severe injection site
reactions, including necrosis or localized infection [see Medication Guide].
Hepatic
Injury
Advise
patients that severe
hepatic injury, including hepatic failure, has been reported
during the use of BETASERON.
Inform
patients of symptoms
of hepatic dysfunction, and instruct patients
to report them immediately to their healthcare provider [see Warnings and
Precautions (5.1)].
Anaphylaxis and Other Allergic
Reactions
Advise
patients of the symptoms of allergic reactions and anaphylaxis, and instruct patients
to seek immediate medical
attention if these symptoms occur [see Warnings and Precautions (5.2)].
Depression and Suicide
Advise
patients that depression and suicidal ideation
have been reported
during the use of BETASERON. Inform patients of
the symptoms of depression or suicidal ideation, and instruct patients to
report them immediately to their healthcare provider [see Warnings and
Precautions (5.3)].
Congestive Heart Failure
Advise
patients that worsening of pre-existing congestive heart failure have been reported
in patients using BETASERON.
Advise
patients of symptoms
of worsening cardiac
condition, and instruct
patients to report them immediately to their healthcare
provider [see Warnings and Precautions (5.4)].
Injection Site Reactions Including Necrosis
Advise patients that injection site
reactions occur in most patients treated with BETASERON, and that injection
site necrosis may occur at one or multiple sites. Instruct patients to promptly
report any break in the skin, which may be associated with blue-black discoloration, swelling, or drainage
of fluid from the injection site, prior to continuing their BETASERON therapy [see Warnings
and Precautions (5.5)].
Pulmonary Arterial Hypertension
Inform patients
that PAH has occurred in patients treated
with interferon beta products, including BETASERON. Instruct
patients to promptly report any new symptoms
such as new or increasing fatigue or shortness of breath to their healthcare provider [see Warnings and
Precautions (5.8)].
Approved Drug Label (PDF)
5
Warnings and Precautions
5.5 Injection Site Reactions Including
Necrosis (formerly
Injection Site Necrosis and Reactions)
Additions and/or revisions underlined:
Injection site reactions, including
injection site necrosis, can occur with the use of interferon beta products,
including BETASERON.
Injection site necrosis (ISN) was reported in 4% of BETASERON-treated patients
in controlled clinical trials (compared to 0% on placebo) [see Adverse Reactions (6.1)] …
… Approximately 69% of patients
experienced injection site reactions during the first three months of
treatment, compared to approximately 40% at the end of the studies. injection
site abscesses and cellulitis have been reported in the postmarketing setting
with use of interferon beta products including BETASERON. Some cases required
treatment with hospitalization for surgical drainage and intravenous
antibiotics. Periodically evaluate patient understanding and use of aseptic
self-injection techniques and procedures, particularly if injection site
necrosis has occurred. Patients should be advised of the importance of
rotating injection sites with each dose. Whether to discontinue therapy
following a single site of necrosis is dependent on the extent of necrosis. For
patients who continue therapy with BETASERON after injection site necrosis has
occurred, avoid administration of BETASERON into the affected area until it is
fully healed. If multiple lesions occur, change injection site, or discontinue
therapy until healing occurs.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions and/or revisions underlined:
What are the possible side effects of
BETASERON?
BETASERON may cause serious side
effects. Call your healthcare provider
right away if you have any of the serious side effects of BETASERON, including:
injection site problems. Serious skin
reactions can happen in some people including areas of severe damage to skin
and the tissue below the skin (necrosis). These reactions can happen anywhere you
inject BETASERON. Symptoms of injection site problems may include swelling,
redness, or pain at the injection site, fluid drainage from the injection site,
and breaks in your skin or blue-black skin discoloration. Call your
healthcare provider right away if an injection site becomes swollen and painful
or the area looks infected. You may have a skin infection or an area of severe
skin damage (necrosis) requiring treatment by a healthcare provider.
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
PLLR
conversion; additions and/or revisions underlined:
Risk
Summary
Although there have been no well-controlled studies
in pregnant women, available data, which includes prospective observational studies,
have not generally indicated a drug-associated risk of major birth defects with
interferon beta-1b during pregnancy. Administration of BETASERON to monkeys
during gestation resulted in increased embryo-fetal death at or above exposures
greater than 3 times the human therapeutic dose.
In the U.S. general population, the estimated
background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth
defects and miscarriage for the indicated population is unknown.
Data
Human Data
The majority of the observational studies
reporting on pregnancies exposed to interferon beta-1b did not identify an association
between the use of interferon beta-1b during pregnancy and an increased risk of
major birth defects.
Animal Data
When BETASERON (doses ranging from 0.028 to
0.42 mg/kg/day) was administered …
8.2 Lactation
PLLR
conversion; additions and/or revisions underlined:
Risk
Summary
There are no data on the presence of BETASERON in human
milk, the effects on the breastfed infant, or the effects of the drug on milk
production.
The developmental and health benefits
of breastfeeding should be considered along with the mother's clinical need for
BETASERON and any potential adverse effects on the breastfed child from
BETASERON or from the underlying maternal condition.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
Pregnancy
Additions
and/or revisions underlined:
Advise patients to
notify their healthcare provider if they are pregnant or plan to become pregnant.
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