Provenge

Provenge is a prescription-only immunotherapy medicine used to treat advanced prostate cancers that do not respond to hormone therapy.

This medicine contains your own modified immune cells (autologous cellular immunotherapy). It is available as suspension.

Before using Provenge, you must know all about the risks and complications associated with it. Together with your doctor, you can decide whether the medication will provide you more goods than the harms.

Here are some factors to be considered before deciding to use this medicine:

Allergies: Inform your doctor about the allergies you have, such as to this medication, other medications, or to foods, dyes, or preservatives.

Pediatric: Safety and efficacy of this medicine in children have not been well documented.

Geriatric: It is generally safe for use in elderly.

Breastfeeding: It may be used in a nursing mother after assessing risks and benefits of the use.

Drug Interactions: Taking two medicines together can be harmful due to possible interactions. In other cases, even if there is a possible interaction between two medicines your doctor may advise you to take them together after adjusting the dose or issuing precautions.

In case you are currently on treatment with any other prescription or nonprescription (over-the-counter: OTC) medicine, inform your doctor.

Other Interactions: Taking your medicine together with certain foods or items such as alcohol or tobacco may cause undesirable interactions. Talk to your doctor to know if using this medicine with food, alcohol, or tobacco is safe.

Medical Problems: Certain medical conditions might influence the effects (both positive and adverse) and action of this medicine.

Inform your doctor about the following conditions, if any:

• Heart disease
• Abnormal heart rhythms
• Lung diseases or breathing difficulties
• History of stroke

To use Provenge properly, you must follow all instructions given by your doctor.

• Your immune cells are removed and stored in the laboratory where they are mixed with specific proteins.
• These modified immune cells are then infused into your vein slowly for about an hour. The treatment completes in 3 infusions at an interval of 2 weeks.
• Painkiller acetaminophen and anti-allergic medicine diphenhydramine may also be administered to prevent infusion reactions.
• Do not skip even a single dose of this medicine as the treatment may not work properly if you do so.

In using Provenge, you must be careful and take some precautions as advised by your doctor. Your progress should be regularly monitored to determine if you are responding to the treatment or to detect any undesirable effect of the medicine.

Talk to your doctor immediately if you experience following side effects some hours after taking Provenge:

• Fever or chills
• Dizziness Rapid heartbeat
• Joint pain
• Nausea and vomiting
• Breathing or vision difficulties
• Excessive tiredness or weakness

Watch for the signs of infection and contact your doctor immediately if you develop:

• Cough
• Fever
• Red or painful areas near the infusion or collection sites.

If you develop any of the following signs indicating troubles of your heart rhythm, consult your doctor immediately:

• Chest pain or discomfort
• Dizziness
• Fainting
• Rapid or irregular heartbeat or pulse

Consult your doctor before taking any prescription or nonprescription medicines and herbal or vitamin supplements.

Make sure you meet with your doctor in using Provenge to avoid unwanted potential side effects.

Consult your doctor immediately if you experience any of the following side effects:

More common:

• Pain in bladder, muscle, back, joint or chest
• Swollen face, arms, hands, lower legs, or feet
• Blood in urine
• Chills
• Confusion
• Cough
• Diarrhea
• Breathing, vision or speech difficulties
• Fever
• Headache
• Decreased appetite
• Stuffy nose
• Yellowish skin
• Tingling sensations in the limbs
• Sleeplessness
• Abnormal bleeding or bruising
• Excessive tiredness
• Unexplained weight gains or loss
• Nausea and vomiting

Mild and non-serious side effects usually go away on their own without requiring medical intervention. You may also ask your doctor to learn more about how you may prevent or reduce the side effects.

Talk to your doctor if the side effects persist or worry you, including:

More common:

• Pain in back, muscles, bone or neck
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Loss of weight
• Dizziness
• Warm, red skin on face, neck, and arms
• Excessive weakness
• Decreased appetite
• Abnormal muscle contractions
• Problem sleeping

Less common:

• Shaking legs, arms, hands, or feet

The side effects of the medicine are not limited to the ones listed above. Call your doctor immediately if you experience any side effects that are uncommon or worry you. To report side effects to the FDA, contact at 1-800-FDA-1088.