Indications and Important Safety Information
What is LIFYORLI?
LIFYORLI is a prescription medicine used with a chemotherapy medicine called nab-paclitaxel to treat adults with ovarian, fallopian tube, or primary peritoneal cancer who:
- Have not responded to or are no longer responding to treatment with platinum-based chemotherapy, and
- Have received 1-3 prior systemic treatments, at least one of which included bevacizumab.
It is not known if LIFYORLI is safe and effective in children.
Important Safety Information
Who should not take LIFYORLI?
Do not take LIFYORLI if you are receiving or taking a steroid medicine by mouth or injection (systemic glucocorticoid) for lifesaving purposes. LIFYORLI can make glucocorticoid medicines less effective.
What are the possible side effects of LIFYORLI?
LIFYORLI can cause serious side effects, including:
Low white blood cell count (neutropenia) and severe infections. LIFYORLI in combination with nab-paclitaxel can cause low white blood cell counts, which can lead to a fever and severe infections and cause death. Your healthcare provider will check your blood counts before each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as needed. Tell your healthcare provider right away if you have a fever, chills, weakness, confusion, or other signs or symptoms of an infection.
Reduced effects of the hormone cortisol (adrenal insufficiency). LIFYORLI reduces the effect of an adrenal hormone called cortisol, which may be life-threatening and require hospitalization. This can happen at any time during treatment. Your risk of adrenal insufficiency is increased when your body is under stress, such as when you are sick, have an infection, or have surgery. Tell your healthcare provider right away if you develop the following symptoms during treatment with LIFYORLI:
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Feeling dizzy or lightheaded
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Low blood pressure (hypotension)
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Low blood sugar (hypoglycemia)
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Worsening weakness or tiredness
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Worsening nausea or vomiting
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Worsening loss of appetite or weight loss
Worsening of conditions treated with glucocorticoids. Treatment with LIFYORLI in people who also take glucocorticoids for other conditions may worsen symptoms of these conditions. LIFYORLI makes glucocorticoids less effective, and use of glucocorticoids makes LIFYORLI less effective. If you take a glucocorticoid medicine during treatment with LIFYORLI, tell your healthcare provider if symptoms of your other condition get worse.
The most common side effects of LIFYORLI in combination with nab-paclitaxel include
Decreased red blood cell, white blood cell, and platelet counts
Tiredness
Nausea
Diarrhea
Rash
Decreased appetite
Your healthcare provider may change your dose of LIFYORLI, delay treatment, or completely stop treatment with LIFYORLI if you have certain side effects. These are not all the possible side effects of LIFYORLI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before you take LIFYORLI, tell your healthcare provider about all your medical conditions, including if you:
Plan to have surgery or have had surgery within the past 30 days
Have liver problems
Are pregnant or plan to become pregnant. LIFYORLI can harm your unborn baby
Females who are able to become pregnant:
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Your healthcare provider should do a pregnancy test before you start treatment with LIFYORLI.
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Use effective birth control (contraception) during treatment with LIFYORLI and for 1 week after your last dose. Talk with your healthcare provider about birth control methods you can use during this time.
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Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with LIFYORLI.
Males with female partners who are able to become pregnant:
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Use effective birth control (contraception) during treatment with LIFYORLI and for 1 week after your last dose.
Are breastfeeding or plan to breastfeed. It is not known if LIFYORLI passes into your breast milk. Do not breastfeed during treatment with LIFYORLI and for 1 week after your last dose.
Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LIFYORLI with certain other medicines may affect how LIFYORLI or the other medicines work and may cause side effects.
Especially tell your healthcare provider if you are taking steroid medicines called glucocorticoids. Ask your healthcare provider if you are not sure if you take a glucocorticoid.
Please see Important Facts about LIFYORLI.
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