Xermelo

Xermelo is a prescription medication used in combination with another medication to control diarrhea caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms like diarrhea) in patients with diarrhea not controlled by a somatostatin analog alone.

Xermelo belongs to a class of medications called antidiarrheal agents. It works by blocking the formation of a certain natural substance in the body that is released by the carcinoid tumors and causes diarrhea.

This medication comes in a tablet form and is taken with food three times a day.

Common side effects of Xermelo include nausea, headache, and flatulence.

Xermelo is a prescription medication used with a somatostatin analog [SSA] therapy such as lanreotide, octreotide, pasireotide to control diarrhea caused by carcinoid tumors (slow-growing tumors that release natural substances that can cause symptoms like diarrhea) in patients with diarrhea not controlled by a somatostatin analog alone.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xermelo. See the “Xermelo Precautions” section.

Common side effects of Xermelo include the following:

• nausea
• headache
• depression
• swelling of your hands, feet, or legs
• gas
• decreased appetite
• fever
• increased GGT (gamma-glutamyl transferase, a substance indicative to liver health)

This is not a complete list of Xermelo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)

• Short-acting octreotide. Concurrent administration of short-acting octreotide with Xermelo may decrease Xermelo effects. If treatment with short-acting octreotide is needed in combination with Xermelo, administer short-acting octreotide at least 30 minutes after administration of Xermelo

This is not a complete list of Xermelo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Xermelo including the following:

• Constipation. Xermelo reduces bowel movement frequency. Your doctor will stop treatment with Xermelo if you develop severe constipation or abdominal pain. Tell your healthcare provider right away if you have some or all of the following symptoms of constipation:
  • Passing fewer than three stools a week.
  • Having lumpy or hard stools.
  • Straining to have bowel movements.
  • Feeling as though there's a blockage in your rectum that prevents bowel movements.
  • Feeling as though you can't completely empty the stool from your rectum.

Do not take Xermelo if you are allergic to Xermelo or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Xermelo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Xermelo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Xermelo or to any of its ingredients
• have severe persistent or worsening stomach pain
• are taking short-acting octreotide (Sandostatin)
• have or ever had liver disease
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Xermelo crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Xermelo.

Take Xermelo exactly as prescribed.

This medication comes in a tablet form and is usually taken with food, three times a day. Each blister-pack contains one day of medicine.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Xermelo at the same time.

Keep taking this medicine, even if you feel better. Stopping or skipping doses can cause your diarrhea to return.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose of Xermelo is 250mg taken three times daily, with food.

If you take too much Xermelo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Xermelo at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature
• Keep this medication in the container it came in, tightly closed, and out of reach of children.