Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Infections
Additions and/or revisions
underlined:
…
In the GAMIFANT clinical trials, additional
infections were reported in patients treated with GAMIFANT including herpes
zoster (2.4%) and mycobacterial infections (2.4%).
…
5.3 Infusion-Related Reactions
Additions and/or revisions underlined:
…
Infusion-related
reactions were defined as any event reported to have occurred within 24 hours
after the start of infusion and assessed as related to GAMIFANT.
In the GAMIFANT clinical
trials, additional infusion-related reactions that were reported in less than
3% of patients treated with GAMIFANT included: malaise, sinus tachycardia,
feeling hot, and acute respiratory failure.
…
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
What is the most
important information I should know about GAMIFANT? GAMIFANT can cause serious
side effects including:
Infections. GAMIFANT is a
medicine that affects your immune system and may lower the ability of your
immune system to fight infections. GAMIFANT may increase your risk of serious
infections that can lead to death. These infections include tuberculosis (TB),
histoplasmosis, pneumonia, cytomegalovirus infection or reactivation of
infection, sepsis, herpes zoster infection (shingles) and other infections
caused by viruses, fungi or bacteria that can spread throughout the body.
…
Before starting
GAMIFANT, tell your healthcare provider if you:
…
currently
have or have had history of infections, including histoplasmosis, cytomegalovirus,
or herpes zoster (shingles).
…
What are the
possible side effects of GAMIFANT? GAMIFANT can cause serious side effects,
including:
See
“What is the most important information
I should know about GAMIFANT?”
Infusion
reactions. Infusion
reactions, including severe reactions, can happen during or within 24 hours after
the start of your GAMIFANT infusion. Your healthcare provider may temporarily
stop your infusion and treat your symptoms before continuing your infusion at
a slower rate if you get severe infusion reactions. Tell your healthcare
provider right away if you get any of the following symptoms:
skin redness
chills
itching
chest pain
fever
shortness of breath
Rash
nausea or vomiting
excessive sweating
lightheadedness or
dizziness
headache
tingling, burning,
or numbness
bone pain
cold hands, arms,
legs or feet
generally feeling
unwell
increased heart rate
feeling hot
The most common
side effects of GAMIFANT in people with primary HLH include: infections, high
blood pressure (hypertension), infusion reactions, and fever.
The most common
side effects of GAMIFANT in people with HLH/MAS in Still’s disease include: viral infection, including
cytomegalovirus infection or reactivation, and rash.
…
Approved Drug Label (PDF)
5
Warnings and Precautions
5.1 Infections
Additions and/or revisions underlined:
…
In patients with primary
HLH receiving GAMIFANT in clinical trials, serious infections such as sepsis,
pneumonia, bacteremia, disseminated histoplasmosis, necrotizing fasciitis,
viral infections, and perforated appendicitis were observed in 32% of patients.
The reported infections were viral (41%), bacterial (35%), fungal (9%), and the
pathogen was not identified in 15% of cases.
In patients with HLH/MAS in Still’s disease receiving GAMIFANT in
clinical trials, serious infections such as pneumonia, cytomegalovirus
infection, cytomegalovirus infection reactivation, and sepsis were observed in
13% of patients. The reported infections were viral (44%), bacterial (13%),
fungal (3%) and the pathogen was not identified in (13%) of patients.
…
5.3 Infusion-Related Reactions
Additions and/or revisions underlined:
Infusion-related
reactions in patients with primary HLH, including drug eruption,
pyrexia, rash, erythema, and hyperhidrosis, were reported with GAMIFANT
treatment in 27% of patients. In one-third of these patients, the
infusion-related reaction occurred during the first infusion.
Infusion-related
reactions in patients with HLH/MAS in Still’s disease, including pyrexia,
headache, paresthesia, bone pain, pruritic rash, and peripheral coldness, were
reported with GAMIFANT treatment in 13% of patients. Infusion related reactions were reported as mild in
8% of patients and as moderate in 5% of patients.
Monitor patients for
infusion-related reactions which can be severe. Interrupt the infusion
for infusion reactions and institute appropriate medical management prior to
continuing infusion at a slower rate.
6
Adverse Reactions
Addition of the
following to the bulleted line listing:
Increased
Risk of Infection with Use of Live Vaccines [see
Warnings and Precautions (5.2)]
6.1 Clinical
Trials Experience
Additions and/or
revisions underlined:
…
Primary HLH
…
HLH/MAS
The safety of GAMIFANT was evaluated in two
open-label clinical studies in patients with HLH/MAS in Still’s disease,
including sJIA [see Clinical Studies (14.2)].
The pooled safety data from these two studies
included 39 patients who received an initial dose of 6 mg/kg followed by 3
mg/kg every 3 days until Day 16, and then twice weekly thereafter. The median
duration of treatment with GAMIFANT was 29 days (range: 7 to 220 days) and the
median cumulative dose was 33 mg/kg (range: 12 to 175 mg/kg).
Serious adverse reactions were reported in 12
patients (31%), with the most common serious adverse reaction being pneumonia
(5%). Fatal adverse reactions occurred in two patients (5%) and included
multiple organ dysfunction and circulatory shock.
Pneumonia led to drug discontinuation in one
patient (3%). The most common adverse reactions (?20%)were viral infections,
including cytomegalovirus infection or reactivation, and rash.
Adverse reactions reported in ? 10% of patients in
the pooled safety analysis up to Week 8 during treatment with GAMIFANT are
presented in Table 5.
Table 5: Adverse
Reactions Reported in greater than or equal to10% of Patients with HLH/MAS in
Still’s disease
Please refer to
label to view Table 5.
8
Use in Specific Populations
8.4 Pediatric Use
Additions and/or revisions underlined:
Safety and effectiveness of GAMIFANT have been
established in pediatric patients, newborn and older, with primary HLH that is
reactivated or refractory to conventional therapies and with HLH/MAS in
Still’s Disease (including sJIA) with an inadequate response to glucocorticoids
[see Clinical Studies (14)]. Use of GAMIFANT is supported by 3
single-arm trials which included 57 pediatric patients: 27 with
primary HLH and 30 with HLH/MAS in Still’s disease. These studies
included pediatric patients in the following age groups: 5 patients newborn to
6 months, 13 patients 6 months to 2 years, 27 patients from 2 years to <12
years, and 12 patients from 12 years to <17 years.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
MEDICATION GUIDE
Additions
and/or revisions underlined:
…
What is GAMIFANT?
GAMIFANT
is a prescription medicine used for the treatment of hemophagocytic
lymphohistiocytosis (HLH) in adults and children (newborn and older) with:
primary
HLH whose disease has come back or progressed, or other medicines have not
worked well enough or cannot be tolerated.
HLH/macrophage
activation syndrome (MAS) in known or suspected Still’s disease,
including systemic Juvenile Idiopathic Arthritis (sJIA), when glucocorticoids
have not worked well enough or cannot be tolerated, or with MAS that has come
back.
…
How will I receive
GAMIFANT?
…
For
HLH/MAS in Still’s disease, after your first dose, GAMIFANT is given
every 3 days for 5 doses, then 2 times a week.
…
What
are the possible side effects of GAMIFANT?
…
The most common
side effects of GAMIFANT in people with HLH/MAS in Still’s disease include: viral infection
and rash.
…
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