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Norvir Advisory

Urgent Message Regarding Abbott's Ritonavir (Norvir)

Abbott Laboratories is experiencing manufacturing difficulties with our HIV protease inhibitor, Norvir (ritonavir) capsules, which will result in a shortage. We have encountered an undesired formation of a Norvir crystalline structure that effects how the capsule form of Norvir dissolves. It is our plan to supply Norvir oral solution (liquid) until we can resume Norvir capsule production and distribution. Norvir capsules currently in distribution are not affected by this issue. When used in accordance with prescribing information, product on the market is safe and effective.

The active ingredients in Norvir liquid and Norvir capsules are identical, as is their activity against HIV. Changing to Norvir liquid should not affect your anti-retroviral regimen. Each Norvir capsule contains 100 mg of active drug, and each mL of Norvir liquid contains 80 mg of active drug. For your convenience, Norvir liquid comes with a dosing cup that provides markings indicating the amount of liquid to be taken for the two most common doses. It is important to measure the correct dose of Norvir; therefore, the dosing cup has been specially designed to provide the right dose of Norvir liquid. This cup should be used to measure a dose. Please be advised that when measuring a dose, the cup should be placed on a flat surface at eye level, and the cup filled with Norvir liquid to the line showing the appropriate dose. You should wash the dosing cup with soap and warm water as soon as possible. The dosing cup is not dishwasher safe.

The following conversion equation may be helpful:

6 - Norvir capsules (100 mg each) = 7.5 mL of Norvir liquid (1 1/2 teaspoons)

4 - Norvir capsules (100 mg each) = 5 mL of Norvir liquid (1 teaspoon)

Patients may improve the taste of Norvir liquid by mixing with chocolate milk, EnsureŽ, or AdveraŽ within one hour of dosing. To ensure continued stability of Norvir liquid, it should not be refrigerated and should be stored at room temperature (below 77°F/25°C) and used within 30 days of dispensing. It is important that you shake the liquid well before each use. Your health care providers have been informed of the dosing and handling for Norvir liquid. People will receive Norvir liquid when their pharmacy runs out of Norvir capsules. After finishing your prescription for Norvir capsules, you should begin taking Norvir liquid at your next scheduled dose. It is critical for you to take your medication at the prescribed dose and time recommended by your physician. If you have questions about the liquid, contact your physician immediately. (For another assessment of the temperature storage recommendations, see Practical Considerations on New Temperature Guidelines for Norvir Liquid.)

Norvir is indicated in adults in combination with other anti-retroviral agents or as monotherapy for the treatment of HIV infection. Norvir has also been cleared by the FDA for use in children between the ages of 2 and 16 based on safety and pharmacokinetic data. Norvir is not a cure for HIV infection. People treated with Norvir may continue to acquire illness associated with advanced HIV infection, including opportunistic infections. Norvir may not be right for everyone, including people with liver disease, hepatitis, or hemophilia. Elevated blood sugar levels have been reported in patients taking protease inhibitors. Allergic reactions ranging from mild to severe have been reported. Common adverse reactions include fatigue, vomiting, diarrhea, loss of appetite, abdominal pain, taste disturbance, tingling sensation or numbness in the hands, feet, or around the lips, headache and dizziness. Norvir should not be used with certain medications including some non-sedating antihistamines, sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations. Talk to your doctor or pharmacist. We deeply regret this inconvenience and appreciate your understanding and patience as we work to solve the problem. Abbott is committed to doing everything it can to allow patients to continue Norvir therapy without interruption, and to resuming timely delivery of Norvir capsules. If you have questions or concerns, please ask your doctor or call us at 1-800-637-2400.

Frequently Asked Questions

Q 1 What steps has Abbott taken to address the problem?

A 1 Abbott is doing everything it can to solve the problem in order to resume production of Norvir capsules as soon as possible. Additionally, Abbott is increasing its production of Norvir oral solution (liquid) in an effort to provide continued Norvir therapy.

Q 2 When will the problem be fixed? When will capsules be available?

A 2 Abbott's Norvir capsule inventory is expected to be available through mid-August. At this time, we do not have a date for when production of capsules will resume. Norvir capsules currently in distribution are not affected by this issue. Norvir capsule production remains the utmost priority for Abbott Laboratories.

Q 3 Can customers be assured that Norvir oral solution (liquid) is not affected by this problem?

A 3 We are continuing thorough testing on all Norvir to ensure that all product released meets quality assurance standards.

Q 4 How does the liquid formulation differ from the capsules?

A 4 Norvir oral solution (liquid) and Norvir capsules are identical in their activity against HIV. Each Norvir capsule contains 100 mg of active drug, and each mL of Norvir liquid contains 80 mg of active drug.

For patient convenience, Norvir liquid comes with a dosing cup that provides markings indicating the amount of liquid to be taken for the two most common doses. It is important to measure the correct dose of Norvir; therefore, the dosing cup has been specially designed to provide the right dose of Norvir liquid. This cup should be used to measure a dose. When measuring a dose, the cup should be placed on a flat surface at eye level. Fill the cup with Norvir liquid to the line showing the appropriate dose. You should wash the dosing cup with soap and warm water as soon as possible. The dosing cup is not dishwasher safe.

After finishing your prescription for Norvir capsules, you should begin taking Norvir liquid at your next scheduled dose. Additionally, Norvir liquid should not be refrigerated. It should be stored at room temperature (below 77°F/25°C) and used within 30 days of dispensing. It is important that you shake the liquid well before each use.

The following conversion equation may be helpful:

6 - Norvir capsules (100 mg each) = 7.5 mL of Norvir liquid or 1 1/2 teaspoons 4 - Norvir capsules (100 mg each) = 5 mL of Norvir liquid or 1 teaspoon

Q 5 Is there a cost difference between Norvir capsules and Norvir oral solution (liquid)?

A 5 Our price for the two formulations is approximately the same.

Q 6 Am I at greater risk for resistance with the Norvir oral solution (liquid) formulation vs. capsules?

A 6 No. Norvir oral solution (liquid) and Norvir capsules are identical in their activity against HIV. With HIV therapies, patient compliance is an essential component in preventing drug resistance. It is critical for you to take your medication at the prescribed dose and time recommended by your health care provider. If you have questions about the liquid, contact your physician immediately.

Q 7 What should I do if I have questions about Norvir oral solution (liquid)?

A 7 You should immediately contact your physician if you have questions about Norvir oral solution (liquid).

Q 8 What if I want to stop therapy and wait to resume protease inhibitor therapy when the capsules are ready?

A 8 Interruption or discontinuation of treatment is not recommended unless advised by a physician. Decisions about treatment should be discussed with a physician and must be individualized to your needs.

Q 9 What if I am combining Norvir with another protease inhibitor?

A 9 Norvir oral solution (liquid) and Norvir capsules are identical in their anti-HIV activity. Changing to Norvir liquid should not affect your anti-retroviral regimen.

Q 10 Can customers be assured that you have adequate Norvir oral solution (liquid) for patients to continue therapy?

A 10 Abbott is increasing production of Norvir oral solution (liquid) in an effort to provide continued Norvir therapy for patients.

Q 11 Am I at greater risk for resistance with the Norvir oral solution (liquid) formulation capsules?

A 11 No. Norvir oral solution (liquid) and Norvir capsules are identical in their activity against HIV. With HIV therapies, patient compliance is an essential component in preventing drug resistance. It is critical for patients to take their medications at the prescribed dose and time recommended by the patient's health care provider. If you have questions about the liquid, contact your physician immediately or call 1-800-637-2400.

Q 12 Are there any issues if I want to switch to an alternative protease inhibitor until Norvir capsules are available?

A 12 A decision to switch therapies should be made in consultation with one's physician. Decisions about treatment should be discussed with a physician and must be individualized to a patient's needs. Do not stop taking your protease inhibitor without first consulting your health care provider.

Q 13 Do I need a new prescription?

A 13 Your pharmacist and physician should be aware of this situation. When your prescription is refilled next, your pharmacist may need to call your physician to secure approval for the switch from Norvir capsules to liquid. No special action should be required on your part.

Q 14 Will this formulation switch require me to see my physician?

A 14 The change from Norvir capsules to liquid should not require a physician visit. The pharmacist may need to call the physician to secure approval for the switch from Norvir capsules to liquid.

Q 15 Should I stop taking my current supply of Norvir capsules?

A 15 No. Norvir capsules currently in distribution are not affected by this issue. It is important that you continue to take Norvir at the prescribed dose and time recommended by your health care provider.

Q 16 Are there any special requirements (like food) for this liquid formulation?

A 16 No. It is recommended that Norvir be taken with meals if possible. The taste of Norvir liquid may be improved by mixing with chocolate milk, EnsureŽ, or AdveraŽ within one hour of dosing.

Posted 8/28/98

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Posted 1/21/99