All About Onivyde

What is Onivyde used for?

Onivyde is used in adults to treat certain types of metastatic pancreatic cancer. (Cancer is metastatic when it has spread to other areas of the body.)

Onivyde is not used by itself. The other drugs it’s given with depend on whether you’ve received past treatment for your pancreatic cancer.

• If the cancer has not yet been treated, Onivyde is prescribed along with fluorouracil, leucovorin, and oxaliplatin.
• If the cancer has been treated with gemcitabine but did not get better, Onivyde is prescribed along with fluorouracil and leucovorin.

The pancreas is behind the stomach, which may make diagnosing pancreatic cancer more difficult. Early stage pancreatic cancer often has no symptoms. When it becomes metastatic, pancreatic cancer may cause symptoms such as jaundice, blood clots, or dark-colored urine. It can also cause digestive symptoms, including reduced appetite, nausea, and vomiting.

Onivyde works to treat pancreatic cancer by blocking a protein that helps cancer cells grow and spread. The active ingredient of Onivyde is protected by a capsule. This helps the drug circulate through your body longer to more effectively reach the tumor.

What are Onivyde’s side effects?

Like most drugs, Onivyde may cause mild to serious side effects. The lists below describe some of the more common side effects this drug may cause. These lists don’t include all possible side effects.

Keep in mind that side effects of a drug can depend on:

• your age
• other health conditions you have
• other medications you take

Your doctor or pharmacist can tell you more about the potential side effects of Onivyde. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a list of some of the mild side effects that Onivyde can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Onivyde’s prescribing information.

Side effects may differ slightly depending on which drugs Onivyde is taken with to treat your pancreatic cancer.

Mild side effects of Onivyde that have been reported include:

• nausea, vomiting, constipation, or diarrhea
• dehydration
• reduced appetite
• weight loss
• feeling tired
• pain in your muscles, bones, ligaments, tendons, or nerves
• abdominal pain
• irritation of the lining of your digestive tract, including in your mouth
• fever
• swelling in your arms and legs from excess fluid
• hair loss
• mild allergic reaction*

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

* To learn more about this side effect, see the “Allergic reaction” section below.

Serious side effects

Serious side effects from Onivyde can occur. If you have serious side effects from Onivyde, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects of Onivyde that have been reported include:

• interstitial lung disease
• pneumonia, sepsis, gastroenteritis, or infection where your IV was placed
• lower amounts of hemoglobin, lymphocytes, or platelets in your blood
• lower or higher amounts of potassium in your blood
• lower or higher amounts of sodium in your blood
• higher results on liver enzyme tests than expected
• lower amounts of calcium or phosphate in your blood
• blood clots, including in your lungs
• shortness of breath
• hemorrhage
• boxed warnings: risk of serious neutropenia and severe diarrhea *
• severe allergic reaction†

* For more information, see the “What should be considered before taking Onivyde?” section.
† To learn more about this side effect, see the “Allergic reaction” section below.

Allergic reaction

Some people may have an allergic reaction to Onivyde.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.

Call your doctor right away if you have an allergic reaction to Onivyde. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What is Onivyde’s dosage?

Your doctor will recommend the dosage of Onivyde that’s right for you. Below are commonly used dosages, but the dosage you receive will be determined by your doctor.

Form and strength

Onivyde comes as a liquid solution that’s given as an intravenous (IV) infusion by your doctor or another healthcare professional. (An IV infusion is an injection into a vein over a period of time.)

The drug comes in one strength of 43 milligrams in 10 milliliters of solution (4.3 mg/mL).

Recommended dosages

Your dosage of Onivyde will be based on your body surface area (BSA)*. It will also depend on whether you’ve received gemcitabine before.

Your doctor may also prescribe a different dosage based on genetic factors that affect how well your body breaks down Onivyde. If you have questions about the dosage that’s right for you, talk with your doctor.

Onivyde is given as an IV infusion every 2 weeks. Your dose will depend on which other medications you’re taking for pancreatic cancer:

• If you’re prescribed Onivyde along with oxaliplatin, fluorouracil, and leucovorin, your doctor will likely prescribe an Onivyde dose of 50 mg/sq m.
• If you’re taking Onivyde along with fluorouracil and leucovorin, your doctor will likely prescribe an Onivyde dose of 70 mg/sq m.

If you experience side effects, your dose may be lowered, or your treatment may be stopped completely. Once your side effects are eased, your doctor may decide to restart your Onivyde treatment.

* BSA is measured in square meters (sq m). It’s a calculation based on your height and weight.

How it’s given

Your doctor will explain how Onivyde will be given to you. They’ll also explain how much you’ll be given and how often.

Onivyde is given as an IV infusion. You’ll receive infusions at your doctor’s office or a clinic. Each infusion will be given over a period of 90 minutes.

About 30 minutes before each infusion, you’ll likely be given a corticosteroid and a medication to reduce the risk of nausea and vomiting.

To learn more about how Onivyde will be given to you, check out the manufacturer’s website.

Questions about taking Onivyde

Below are some common questions about taking Onivyde.

• What if I miss a dose of Onivyde? If you miss an appointment to receive an infusion of Onivyde, call your doctor’s office as soon as possible to reschedule.
• Will I need to receive Onivyde long term? Onivyde is typically used as a long-term treatment. If you and your doctor determine that it’s safe and effective for your condition, you’ll likely receive it long term.
• How long does Onivyde take to work? Onivyde begins to work after your first dose. You likely won’t feel the drug working in your body, but you may experience side effects. Your doctor will monitor you during treatment to make sure the drug is working to treat your condition.

What should be considered before taking Onivyde?

Below is important information you should consider before taking Onivyde.

Interactions

Taking a drug with certain medications, vaccines, foods, and other things can affect how the drug works. These effects are called interactions.

Onivyde can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before starting Onivyde treatment, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also, tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, talk with your doctor or pharmacist.

Drug interactions

Below is a list of medications that can interact with Onivyde. This list does not contain all drugs that may interact with Onivyde. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Onivyde and alcohol

Alcohol is not known to interact with Onivyde. But alcohol may make certain side effects of Onivyde, such as dehydration, worse. Because of this, your doctor may recommend that you limit the amount of alcohol you drink during your Onivyde treatment.

Other interactions

Onivyde can interact with other substances such as:

• Vitamins or supplements: Onivyde interacts with St. John’s wort. Your doctor will likely recommend that you avoid taking this supplement during your Onivyde treatment.
• Foods: Onivyde interacts with grapefruit and grapefruit juice. Your doctor will likely recommend that you do not consume grapefruit products during your Onivyde treatment.

Pregnancy and breastfeeding

Onivyde is not safe to receive during pregnancy or while breastfeeding. You should not breastfeed during your Onivyde treatment or for 1 month after your last dose.

Birth control

If you can become pregnant, you should use birth control during Onivyde treatment and for at least 7 months after your last dose. Males* with a partner who can become pregnant should use condoms during Onivyde treatment and for at least 4 months after the last dose.

*In this article, we use the term “male” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

Boxed warnings

Onivyde has boxed warnings about the risk of serious neutropenia and severe diarrhea. A boxed warning is the most serious warning from the Food and Drug Administration (FDA) about drug effects that may be dangerous.

Risk of serious neutropenia: Receiving Onivyde increases your risk of developing serious neutropenia, which may be fatal in rare cases. With neutropenia, you have a low level of neutrophils (a type of white blood cell).

Having neutropenia from Onivyde may increase your risk of developing serious infections and sepsis. Because of this risk, your doctor will likely pause your Onivyde treatment if your neutrophils drop to a certain level, or if your neutrophils are very low and you also have a fever. Your doctor may choose to restart your Onivyde treatment once your levels return to a healthy range. But when restarting treatment, your doctor may prescribe a lower dose.

Your doctor will also likely test your blood at certain points during your treatment to make sure your neutrophils are within a healthy range.

Risk of severe diarrhea: Receiving Onivyde also increases your risk of developing severe diarrhea, which can lead to dehydration. You may experience diarrhea within 24 hours of receiving a dose of Onivyde, or it may be delayed by more than a day. This diarrhea may be life threatening in some cases. If you experience diarrhea after an Onivyde infusion, let your doctor know right away.

Due to this risk, your doctor will likely not prescribe Onivyde if you have a blockage in your intestines. To learn more, talk with your doctor.

To reduce your risk of serious diarrhea while taking Onivyde, your doctor may recommend following a low fat diet and avoiding foods with lactose.

If you develop diarrhea within 24 hours after receiving an Onivyde infusion, your doctor will likely give you the drug atropine to help ease this side effect. You’ll receive atropine either as an IV infusion or as an injection under your skin.

If you develop diarrhea more than 24 hours after a dose, your doctor may prescribe loperamide to help. If your diarrhea does not improve after 48 hours, you may need other medications.

Once diarrhea subsides, your doctor may choose to restart your Onivyde treatment at a reduced dose.

Other warnings

Onivyde can sometimes cause harmful effects in people who have certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether Onivyde is a good treatment option for you.

Talk with your doctor about your health history before you receive Onivyde. Be sure to tell them if any of the following factors apply to you:

• blockage in your intestine
• have certain lung diseases or have used certain drugs that may irritate your lungs
• have received radiation before
• previous allergic reaction to Onivyde or any drug containing irinotecan (Onivyde’s active ingredient)
• pregnancy
• breastfeeding

Find answers to some commonly asked questions about Onivyde.

How does Onivyde compare with Camptosar or Xeloda?

Both Onivyde and capecitabine (Xeloda) are used to treat certain types of pancreatic cancer. Either drug is typically prescribed along with one or more other chemotherapy drugs.

Onivyde and Xeloda come in different forms. Onivyde is given as an intravenous (IV) infusion by your doctor or another healthcare professional, while Xeloda comes as an oral tablet.

Camptosar may be used off-label for pancreatic cancer. (With off-label use, a doctor prescribes a drug for a purpose other than what it was approved for.) Camptosar contains the same active ingredient as Onivyde, irinotecan. But Camptosar and Onivyde contain different forms of irinotecan. Camptosar contains the hydrochloride form. Onivyde contains the liposome form, which may keep the drug circulating in your body longer. Both Camptosar and Onivyde are given by IV infusion.

Onivyde and Camptosar belong to the same group of drugs. Although Xeloda belongs to a different drug group, all three are types of chemotherapy.

If you have other questions about how Onivyde compares with Camptosar or Xeloda, talk with your doctor. They recommend the best treatment for you.

Is Onivyde part of the NALIRIFOX chemotherapy regimen?

Yes. NALIRIFOX may be prescribed as your first treatment for metastatic pancreatic cancer. (Cancer is metastatic when it has spread to other areas of the body.) The following drugs are part of the NALIRIFOX regimen:

• irinotecan liposome (Onivyde)
• fluorouracil
• leucovorin
• oxaliplatin (Eloxatin)

Will Onivyde cure my pancreatic cancer?

No, Onivyde is not expected to cure metastatic pancreatic cancer. There’s currently no cure for this condition. However, Onivyde may help slow the spread of existing cancer cells or the growth of new ones.

If you have other questions about what to expect from your Onivyde treatment, talk with your doctor.

Onivyde cost

Whether you have health insurance or not, cost may be a factor when you’re considering Onivyde. What you’ll pay for Onivyde may depend on several things, such as your treatment plan and the pharmacy you use.

You can also check out this article to learn more about saving money on prescriptions.

Similar drugs

Other drugs are available that may be able to treat your condition. If you’d like to explore an alternative to Onivyde, talk with your doctor. They can tell you about other medications that might work well for you.

The following drugs may also be used to treat pancreatic cancer that’s metastatic:

• gemcitabine with paclitaxel (Abraxane)
• FOLFOX regimens, which contain leucovorin, fluorouracil, and oxaliplatin (Eloxatin)