A. Talk to your healthcare provider about birth control choices that are right for you during this time.
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Males who have female partners who are able to become pregnant should use effective birth control during treatment with LORBRENA and for at least 3 months after the final dose of LORBRENA.
are breastfeeding or plan to breastfeed. It is not known if LORBRENA passes into your breast milk. Do not breastfeed during treatment with LORBRENA and for 7 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
How should I take LORBRENA?
Take LORBRENA exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking LORBRENA unless your healthcare provider tells you to.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with LORBRENA if you develop side effects.
Swallow LORBRENA tablets whole. Do not chew, crush, or split LORBRENA tablets. Do not take LORBRENA tablets if they are broken, cracked, or not intact.
Take LORBRENA at approximately the same time each day.
You may take LORBRENA with or without food.
If you miss a dose, take it as soon as you remember. However, if it is close to the time of your next dose (within 4 hours), just take your next dose at your regular time.
If you vomit after taking a dose of LORBRENA, do not take an extra dose. Take your next dose at your regular time.
What are the possible side effects of LORBRENA?
See "What is the most important information I should know about LORBRENA?"
The most common side effects of LORBRENA include:
swelling in your arms, legs, hands and feet (edema)
numbness and tingling feeling in your joints or arms and legs (peripheral neuropathy)
difficulty thinking or confusion
difficulty breathing
tiredness (fatigue)
weight gain
pain in your joints
changes in mood, feeling sad or anxious
diarrhea
LORBRENA may cause decreased fertility in males. In males, this could affect your ability to father a child. Talk to your healthcare provider if you have concerns about fertility.
These are not all of the possible side effects of LORBRENA. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LORBRENA?
Store LORBRENA at room temperature between 68°F to 77°F (20°C to 25°C).
Keep LORBRENA and all medicines out of the reach of children.
General information about the safe and effective use of LORBRENA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LORBRENA for a condition for which it was not prescribed. Do not give LORBRENA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about LORBRENA that is written for health professionals.
What are the ingredients in LORBRENA?
Active ingredient: lorlatinib
Inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, sodium starch glycolate, and magnesium stearate.
Film-coating contains: hydroxypropyl methylcellulose (HPMC) 2910/hypromellose, lactose monohydrate, macrogol |
