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Details for: ADDYI

Company: SEARCHLIGHT PHARMA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02473550ADDYIFLIBANSERIN100 MGTABLETORAL
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Summary Reports

Summary Basis of Decision
Regulatory Decision Summary

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

ADDYI is used to treat a condition called hypoactive sexual desire disorder (HSDD) in women. This means that you have had low sexual desire for a minimum of 6 months that happens 75 - 100% of the time and this causes you distress or difficulty in your relationships.

It is used in pre and naturally postmenopausal women, aged 60 years or younger, who:

  • have not had problems with low sexual desire in the past
  • have low sexual desire no matter the type of sexual activity, the situation or the sexual partner
Your healthcare professional may use a checklist to decide if ADDYI is right for you. They may prescribe ADDYI to you only if your low sexual desire is NOT due to:
  • a medical or mental health problem
  • problems in the relationship
  • medicine or other drug use
ADDYI does not improve sexual performance.
What it does

ADDYI is a medicine that adjusts chemicals in your brain. These chemicals, called dopamine and serotonin, are involved in sexual interest and desire. The exact way that ADDYI works is not known.

When it should not be used

Do not use ADDYI if:

  • You are allergic to flibanserin or any of the other ingredients in ADDYI.
  • You have liver problems.
  • You are pregnant.
  • You are breastfeeding.
  • You have low blood pressure and you drink alcohol.
  • You are a man.
  • You are under 18 years old.
  • You are over 60 years old.
  • You take a drug called digoxin or a similar type of drug.
  • Taking ADDYI with certain other medicines can increase the amount of ADDYI in your blood and this can cause severe low blood pressure, fainting (loss of consciousness) and sleepiness. Before taking ADDYI, tell your healthcare professional about all the medicines you take. They will tell you if it is safe to take ADDYI.

Do not take ADDYI if you are taking any of the following medicines:

  • certain medicines used to treat HIV-1 infection such as:
    • amprenavir
    • atazanavir
    • fosamprenavir
    • ritonavir
    • saquinavir
    • nelfinavir
    • indinavir
  • certain medicines that you take by mouth used to treat fungal infections such as:
    • fluconazole
    • ketoconazole
    • itraconazole
    • posaconazole
  • certain antibiotics, including:
    • ciprofloxacin
    • erythromycin
    • telithromycin
    • clarithromycin
  • certain medicines used to treat Hepatitis C infection such as:
    • boceprevir
    • telaprevir
  • certain medicines used to treat high blood pressure, chest pain (angina), or other heart problems such as:
    • diltiazem
    • verapamil
  • certain medicines used to treat depression, such as nefazodone

Do NOT drink grapefruit juice when taking ADDYI.

What the medicinal ingredient is

Medicinal ingredients: flibanserin

What the non-medicinal ingredients are

Non-medicinal ingredients: croscarmellose sodium, hypromellose, iron oxide red, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide.

What dosage form it comes in

100 mg tablets

Warnings and precautions

Serious Warnings and Precautions

  • ADDYI can cause severe low blood pressure and fainting.
  • Take ADDYI at bedtime. If you take ADDYI and feel lightheaded or dizzy, lie down right away. Drinking alcohol close to the time you take ADDYI increases your risk of severe low blood pressure and fainting.
  • ADDYI can cause sedation or make you feel very drowsy. After taking ADDYI, do not drive or perform other activities that require full attention until you know how it affects you. Using ADDYI with depressant drugs may increase the risk of sedation or drowsiness.
  • You should not take ADDYI if you have liver problems.
  • ADDYI should not be taken if you are taking certain other medicines. Before taking ADDYI, tell your healthcare professional about all the medicines you take. They will tell you if it is safe to take ADDYI.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ADDYI. Talk about any health conditions or problems you may have, including if you:

  • have low blood pressure.
  • have a medical condition that can cause low blood pressure.
  • have heart problems.
  • are pregnant or trying to get pregnant.
  • are breastfeeding or planning to breastfeed.
  • drink alcohol.
  • have been told that you have a variation in a liver enzyme called CYP2C19 which makes you process certain medicines poorly.
  • have experienced allergic reactions or sensitivity to any medicines.

Other warnings you should know about:

Race/Ethnicity and Body Mass Index (BMI) in Postmenopausal Women:

  • The effects of ADDYI were not studied in Black or Asian women who are postmenopausal, or postmenopausal women who are underweight.
  • If you weigh less than 50 kg, there might be a higher risk of certain side effects. These side effects include central nervous system depression (sedation or feeling very sleepy), low blood pressure and fainting. Tell your healthcare professional right away if you feel these effects.

Alcohol:

  • Drinking alcohol close to the time you take ADDYI increases your risk of severe low blood pressure, fainting and central nervous system depression like sleepiness. Wait at least 2 hours after drinking 1 or 2 standard alcoholic drinks before taking ADDYI at bedtime. Examples of 1 standard alcoholic drink include:
    • one 12-ounce regular beer (5% alcohol).
    • 5 ounces of wine (12% alcohol).
    • 1.5 ounces of distilled spirits or shot (40% alcohol).
  • If you drink 3 or more standard alcoholic drinks in the evening, skip your ADDYI dose at bedtime. After you have taken your ADDYI at bedtime do not drink alcohol until the following day.

Driving and using machines:

  • ADDYI can cause low blood pressure, fainting (loss of consciousness) and sleepiness. Using ADDYI with drugs (like diphenhydramine, opioids, hypnotics and benzodiazepines) that slow down your central nervous system can increase this risk. This can affect your ability to drive or use machines. You should not drive or perform other activities that need full attention after taking ADDYI until you know how it affects you. You should be extra careful when driving the morning after taking ADDYI until you know how it affects you.

Low blood pressure and fainting:

  • The risk of low blood pressure and fainting is increased if ADDYI is taken during waking hours or if more than the recommended amount is taken. This is why you must take ADDYI at bedtime only and exactly as your doctor tells you to. If you take ADDYI and feel lightheaded or dizzy, lie down right away. Get immediate medical help or ask someone to get immediate medical help for you if the symptoms do not go away or if you faint (lose consciousness). If you faint, tell your healthcare professional as soon as you can.

Severe Allergic Reactions:

  • Anaphylactic reactions (severe allergic reactions) may happen while taking ADDYI. Tell your healthcare professional right away if you have a hard time breathing or a serious rash.
Interactions with this medication

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ADDYI:

  • digoxin, a medicine used to treat heart problems
  • medicines called proton pump inhibitors used to treat acid reflux such as esomeprazole or omeprazole
  • ranitidine, which is a medicine used to treat stomach ulcers, indigestion and heartburn
  • selective serotonin reuptake inhibitors such as fluoxetine
  • benzodiazepines such as diazepam or lorazepam
  • medicines used to treat seizures such as carbamazepine, phenobarbital and phenytoin
  • rifampin and rifabutin, which are medicines used to treat tuberculosis
  • etravirine, which is a medicine used to treat HIV-1 infection
  • non-steroidal anti-inflammatory drugs (NSAIDS) such as acetylsalicylic acid (ASA) and ibuprofen
  • birth control pills
  • alcohol
  • certain herbal supplements such as St. John’s Wort, ginkgo and resveratrol
  • certain non-prescription medicines such as cimetidine
  • sleeping pills such as zopiclone and zolpidem
  • certain antihistamines (anti-allergy medicines) such as diphenhydramine
  • narcotic pain relievers such as codeine, fentanyl and hydrocodone

Proper use of this medication

How to take ADDYI:

  • Take ADDYI exactly as your doctor tells you to. They will tell you how to safely take this drug.
  • Do not take more than the dose prescribed by the healthcare professional.
  • Take ADDYI at bedtime only.
  • Never take ADDYI at another time of the day. If you take ADDYI at a time other than bedtime you might get low blood pressure, faint (lose consciousness), get very sleepy and possibly injure yourself by accident.
  • Talk to your healthcare professional if your symptoms of HSDD have not gotten better after taking ADDYI for 8 weeks.

Usual Dose:

One ADDYI tablet once a day at bedtime.

Overdose:

If you think you, or a person you are caring for, have taken too much ADDYI, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

  • If you miss a dose of ADDYI, skip your missed dose.
  • Take your next dose at bedtime the next day.
  • Do not take ADDYI the next morning.
  • Do not double your next dose.
Side effects and what to do about them

These are not all the possible side effects you may have when taking ADDYI. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

  • dizziness
  • vertigo
  • nausea, vomiting
  • muscle spasms
  • • swelling of hands and legs
  • sleepiness, tiredness
  • night sweats
  • difficulty falling asleep or staying asleep
  • dry mouth
  • anxiety
  • diarrhea
  • constipation
  • indigestion
  • abdominal pain
  • headache
  • abnormal dreams
  • rash
  • acne

Your healthcare professional may decide to do some liver tests. They will tell you if your test results are abnormal and if you need treatment.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
COMMON
Sinusitis (inflammation or swelling of sinus tissue): ✔    
Urinary tract infection (infection in urinary system including kidneys, ureters, bladder and urethra): Pain or burning sensation while urinating, frequent urination, blood in urine, pain in the pelvis, strong smelling urine, cloudy urine   ✔  
UNCOMMOON
Fainting (loss of consciousness)     ✔
Hypersensitivity (severe allergic reaction): fever, skin rash, hives, itching, swelling, shortness of breath, wheezing, runny nose, itchy, watery eyes     ✔
Low blood pressure: blurred vision, dizziness or lightheadedness, feeling tired, nausea.   ✔  
Mental health changes: dissociation from reality, hallucination, intensely excited mood, racing thoughts.     ✔
Tachycardia (abnormally fast heartbeat): chest pain, fast pulse, lightheadedness, racing or irregular heartbeat, shortness of breath.     ✔

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

How to store

Store ADDYI at 15°C-30°C. Keep out of reach and sight of children. Ask your healthcare professional or pharmacist on how to safely throw away ADDYI tablets.

Reporting side effects

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about ADDYI:

This leaflet was prepared by Searchlight Pharma Inc. Last Revised January 26, 2021

Date modified: