IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ELAHERE?
ELAHERE can cause serious side effects, including:
Eye problems. Eye problems are common with
ELAHERE and can also be severe. Tell your healthcare provider right away
if you develop any eye problems during treatment with ELAHERE, including
blurred vision, dry eyes, sensitivity to light, eye pain, eye redness,
or new or worsening vision changes.
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Your healthcare provider will send you to see an eye care professional
to check your eyes before you start treatment with ELAHERE, during
treatment with ELAHERE, and as needed for any worsening signs and
symptoms of eye problems.
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Your healthcare provider will prescribe steroid eye drops and
lubricating eye drops before you start and during your treatment with
ELAHERE. You should use eye drops as directed by your healthcare
provider.
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Do not wear contact lenses throughout your treatment with ELAHERE
unless you are told to use them by your healthcare provider.
What should I tell my healthcare provider before receiving ELAHERE?
Tell your healthcare provider about all of your medical conditions,
including if you:
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and
herbal supplements. Taking certain other medicines during treatment with
ELAHERE may cause side effects.
What are the possible side effects of ELAHERE?
ELAHERE can cause serious side effects, including:
-
Eye problems. Eye problems are common with
ELAHERE and can also be severe. Tell your healthcare provider right
away if you develop any eye problems during treatment with ELAHERE,
including blurred vision, dry eyes, sensitivity to light, eye pain,
eye redness, or new or worsening vision changes.
-
Lung problems (pneumonitis). ELAHERE can
cause severe or life-threatening inflammation of the lungs that may
lead to death. Tell your healthcare provider right away if you get new
or worsening symptoms, including trouble breathing, shortness of
breath, cough, or chest pain.
-
Peripheral neuropathy. Nerve problems called
peripheral neuropathy are common during treatment with ELAHERE and can
also be severe. Your healthcare provider will monitor you for signs
and symptoms of nerve problems. Tell your healthcare provider if you
get new or worsening numbness, tingling, burning sensation or pain in
your hands or feet or muscle weakness.
The most common side effects and abnormal labs of ELAHERE include:
- increased liver enzymes in the blood
- feeling tired
- blurred vision
- nausea
- diarrhea
- stomach-area (abdominal) pain
- changes in the cornea (part of the eye)
- peripheral neuropathy
- muscle, bone, or joint pain
- decreased red or white blood cell counts
- decreased platelets
- decreased magnesium level in the blood
- dry eye
- constipation
- vomiting
- decreased albumin level in the blood
- decreased appetite
Your healthcare provider may change your dose of ELAHERE, delay
treatment, or completely stop treatment if you have certain side
effects.
These are not all of the possible side effects of ELAHERE. Call your
doctor for medical advice about side effects. You are encouraged to
report side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch
or call
1‑800‑FDA‑1088.
What is ELAHERE?
ELAHERE is a prescription medicine used to treat adults with folate
receptor-alpha positive ovarian cancer, fallopian tube cancer, or
primary peritoneal cancer who:
-
have not responded to or are no longer responding to treatment with
platinum-based chemotherapy and
- have received 1 to 3 prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that ELAHERE
is right for you.
It is not known if ELAHERE is safe and effective in children.
Please see
Full Prescribing Information, including Boxed WARNING and
Medication Guide.
