JATENZO is a brand of testosterone undecanoate available as oral gelatin capsules containing the active ingredient in the form of a fatty-acid ester. It belongs to the androgen drug class. The capsules come in three dosage strengths: 158 mg, 198 mg, and 237 mg, intended for oral use. Key inactive ingredients include oleic acid, borage seed oil, and peppermint oil.

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label at the same time every day. Take it with food. Do not take your medication more often than directed. Keep taking it unless your care team tells you to stop. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Call your care team if you are not sure how to handle a missed dose.

Where should I keep my medication?

Keep out of the reach of children and pets. Store between 15 and 30 degrees C (59 and 86 degrees F). Avoid exposing the capsules to moisture (store in a dry place). Throw away any unused medication after the expiration date on the label.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain -Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded -Increase in blood pressure -Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue -Mood swings, irritability, or hostility -Prolonged or painful erection -Sleep apnea—loud snoring, gasping during sleep, daytime sleepiness -Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision -Swelling of the ankles, hands or feet -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Acne -Burping -Change in sex drive or performance -Diarrhea -Unexpected breast tissue growth -Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Cancer -Depression -Diabetes -Heart disease -High blood pressure -High red blood cell levels -Kidney disease -Liver disease -Lung or breathing disease -Prostate disease -Suicidal thoughts, plans, or attempt by you or a family member -An unusual or allergic reaction to testosterone, other medications, foods, dyes, or preservatives -If you or your partner are pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

-Certain medications for colds or congestion, like ephedrine, phenylephrine, or pseudoephedrine -Certain medications that treat or prevent blood clots like warfarin -Medications for diabetes -Steroid medications like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. They will need to check the level of testosterone in your blood. Heart attacks and strokes have been reported with the use of this medication. Get emergency help if you develop signs or symptoms of a heart attack or stroke. Talk to your care team about the risks and benefits of this medication. This medication may affect blood sugar levels. If you have diabetes, check with your care team before you change your diet or the dose of your diabetic medication. This medication is banned from use in athletes by most athletic organizations.

What are the most serious risks of this medication?

This medicine can cause high blood pressure. Your healthcare provider should monitor your blood pressure regularly while you take this medicine.