Consumer Information for: NATESTO

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

What is NATESTO used for?

  • Testosterone replacement therapy in adult males for conditions where your body is not making enough or any testosterone.
    • It is not known if NATESTO is safe or effective to treat you if you have low testosterone due to aging alone.
What it does

NATESTO contains testosterone. NATESTO delivers testosterone into your bloodstream through your nose. NATESTO helps raise your testosterone to normal levels. Your healthcare professional will test the testosterone level in your blood before you start and while you are using NATESTO.

When it should not be used

Do not use NATESTO if you:

  • have or it is suspected that you have prostate or breast cancer;
  • have a known allergy to any of the ingredients in NATESTO including the medicinal; ingredient testosterone, which is made from soy;
  • are a woman. Pregnant and breast feeding women are especially at risk. Testosterone may cause harm to an unborn baby. Testosterone exposure during pregnancy has been associated with birth defects
What the medicinal ingredient is

Testosterone.

What the non-medicinal ingredients are

Castor oil, colloidal silicon dioxide, oleoyl polyoxylglycerides.

What dosage form it comes in

Nasal gel, 4.5% w/w (5.5 mg of testosterone per actuation).

Warnings and precautions

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

  • have difficulty urinating due to an enlarged prostate. Older patients may have a higher risk of developing an enlarged prostate or prostate cancer;
  • have any type of cancer, especially cancer that has spread to the bones;
  • have liver, kidney or heart problems;
  • have high blood pressure;
  • have diabetes;
  • have breathing problems during sleep (sleep apnea);
  • have heart or blood vessel problems or a history of these problems such as heart attack, stroke, or blood clot in the lungs or legs;
  • have or have had nose (nasal) or sinus problems or nasal or sinus surgery;
  • have had a broken nose (fracture) within the past 6 months;
  • have or have had a fracture of your nose that caused the inside of your nose to be crooked (deviated anterior nasal septum);
  • have or have had problems with swelling of the lining of your nose (mucosal inflammatory disorder).

Other warnings you should know about:

  • Children and women should avoid contact with NATESTO.
    • In children, signs of testosterone exposure can include unexpected sexual development such as inappropriate enlargement of the penis or clitoris, development of pubic hair, increased erections, or aggressive behaviour.
    • In women, signs of testosterone exposure include changes in body hair distribution, significant increase in acne, or other signs of the development of masculine traits.
  • NATESTO must not be used by children under the age of 18. Improper use of NATESTO may affect bone growth in children.
  • There is very little information from clinical trials with testosterone in the older male (> 65 years of age) to support safe use of NATESTO for a long period of time.
  • You should not use testosterone in an attempt to reduce weight and increase muscle, or improve athletic performance as it may cause serious health problems.
  • You should not use testosterone to treat sexual dysfunction or male infertility.
  • NATESTO contains testosterone, which is a controlled substance under Schedule G of the Food and Drugs Act. Keep your NATESTO in a safe place to protect it. Never give your NATESTO to anyone else, even if they have the same symptoms you have.

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

Interactions with this medication

The following may interact with NATESTO:

  • insulin used to treat diabetes;
  • corticosteroids used to treat joint pain and swelling;
  • propranolol used to treat heart problems such as chest pain and high blood pressure;
  • medication used to prevent clotting such as warfarin;
  • St. John’s Wort an herbal product used to treat depression.
Proper use of this medication

How to take NATESTO:

  • It is important that you apply NATESTO exactly as your healthcare professional tells you to.
  • Your healthcare professional will tell you how much NATESTO to apply and when to apply it.
  • NATESTO is to be applied into the nose (intranasally) only. Do not apply NATESTO to any other parts of your body such as your scrotum, penis, abdomen, shoulders, axilla, or upper arms.
  • NATESTO can be used with nasal spray decongestants such as oxymetazoline. NATESTO should not be used with any other nasal sprays.

Supplies needed to give your NATESTO dose:

  • 1 NATESTO dispenser;
  • 2 clean, dry tissues;
  • A clean and flat surface, like a table;
  • A mirror.
Parts of your NATESTO dispenser (See Figure A): How to prime your NATESTO pump:
  • Before you use NATESTO for the first time, you will need to prime your NATESTO pump.
  • Hold your NATESTO dispenser over a sink, turn it upside down and slowly press and release the pump 10 times (See Figure B).
  • Any gel that comes out when you prime your pump should be rinsed down the sink with warm water.
  • If there is any gel on the tip of your actuator after priming, wipe the tip with a clean, dry tissue.
  • If any gel gets on your hands, wash your hands with warm water and soap.
How to administer NATESTO:
  • Blow your nose.
  • Remove the cap from the dispenser.
  • While looking in the mirror, place the right index finger on the pump of your NATESTO actuator and slowly slide the tip of the actuator into the left nostril until the finger on the pump touches the bottom of your nose (See Figure C).
  • Slightly tilt the actuator so that the opening in the tip touches the inside wall of your nostril to ensure that the gel is applied in the correct place (See Figure D).
  • With the actuator in place, slowly push down on the pump until it stops.
  • Remove the actuator from your nose while wiping the tip along the inside wall, to make sure all the gel stays in the nose.
  • While looking in the mirror, put your left index finger on the pump of your NATESTO actuator and slowly slide the tip of the actuator into the right nostril until the finger on the pump touches the bottom of the your nose (See Figure E).
  • Slightly tilt the actuator so that the opening in the tip touches the inside wall of your nostril to ensure that the gel is applied in the correct place (See Figure F).
  • With the actuator in place, slowly push down on the pump until it stops.
  • Remove the actuator from your nose while wiping the tip along the inside wall to make sure all the gel stays in the nose.
  • Wipe the tip of the actuator with a clean, dry tissue.
  • Replace the cap.
  • Press your nostrils together just below the middle of your nose (bridge) and lightly rub them together (See Figure G).
  • Do not blow your nose or sniff for 1 hour after using NATESTO
  • Do not lay down for 1 hour to avoid post-nasal drip.
When to replace NATESTO:
Replace your NATESTO dispenser when the top of the piston inside the dispenser reaches the arrow at the tip of the inside label. The inside label may be found by unwrapping the outer flap from around the container (See Figure H).

Usual Dose

The recommended starting therapy is two doses (1 dose = 1 actuation per nostril) per day for a total of 22 mg. Each actuation contains 5.5 mg of testosterone.
Your dose may be increased by your healthcare professional to 33 mg/day applied in three doses (1 dose = 1 actuation per nostril).
Doses must be at least 6 hours apart. The night dose should be taken at least 1 hour before laying down for bed.

Daily Prescribed Dose Each dose requires one actuation per nostril
22mg Apply NATESTO to each nostril once in the morning and once in the evening, at the same time each day.
33mg Apply NATESTO to each nostril once in the morning once in the afternoon and once in the evening, at the same time each day.

Overdose

If you think you have taken too much NATESTO, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you missed a dose of NATESTO, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking NATESTO. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • acne;
  • metallic and/or unpleasant taste;
  • cough;
  • muscle pain;
  • sleep disturbances caused by breathing problems;
  • loss of hair and baldness;
  • weight gain;
  • headache, dizziness;
  • lowered sperm count;
  • nose problems:
    • abnormal or unpleasant odour;
    • constant runny nose, congestion, sneezing;
    • nose bleed;
    • discomfort in the nose, scabbing, dryness.

NATESTO can increase your risk for prostate cancer. Your healthcare professional should check your prostate before you start taking NATESTO and regularly during your treatment.

NATESTO can cause abnormal blood test results, including an increase in prostatic specific antigen (PSA). Your healthcare professional will decide when to perform blood tests and will interpret the results.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
Common
Benign prostatic hyperplasia (BPH): urinary symptoms such as change in frequency/ colour, dribbling, pain on urination straining, weak stream, small amounts   ✔  
Gynecomastia: breast enlargement or breast pain   ✔  
Uncommon
Edema: swelling of ankles and legs   ✔  
Priapism: unwanted erections that are too frequent or continue for too long   ✔  
Liver problems: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite   ✔  
Abnormal Heart Rhythm: fast or irregular heart beat   ✔  
High Blood Pressure: headaches, shortness of breath, vision problems   ✔  
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Changes in Mood: sad mood (depression), aggression, anger, hostility   ✔  
Blood Clot in the Lung: sharp chest pain, coughing up blood, shortness of breath     ✔
Blood Clot in the Leg: pain, redness, swelling and tenderness in the leg     ✔
Heart attack: crushing chest pain, tightness, pressure or squeezing, pain in the arm, jaw or back, trouble breathing, anxiety, sweating     ✔
Stroke: a sudden severe headache, vomiting, dizziness, fainting, problems with your vision or speech, weakness, or numbness in the face, arm or leg     ✔

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

How to store

Store NATESTO at room temperature (15°C-30°C). Keep out of reach and sight of children and pets.

Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about NATESTO:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.aceruspharma.com, or by contacting Acerus Pharmaceuticals Corporation at 1-844-850-1642 or at AcerusPV@innomarstrategies.com.

Natesto® is a registered trademark of Acerus Biopharma Inc.

This leaflet was prepared by Acerus Pharmaceuticals Corporation.

Date of Revision: April 4, 2019

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