17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)
General Administration Information [see Dosage and Administration ( 2)] :
• Advise patients and caregivers to pay special attention to accurate preparation and administration of their dose to minimize the risk of accidental overdose or underdose of ritonavir.
• Advise caregivers to inform their healthcare provider if their child's weight changes in order to make sure that the child's ritonavir dose is adjusted as needed.
• Advise patients to take ritonavir with meals.
• For adult patients taking ritonavir tablets, the maximum dose of 600 mg twice daily by mouth with meals should not be exceeded.
• Advise patients to remain under the care of a physician while using ritonavir and to take ritonavir and other concomitant antiretroviral therapy every day as prescribed. Ritonavir must always be used in combination with other antiretroviral drugs. Advise patients not to alter the dose or discontinue therapy without consulting with their healthcare provider. If a dose of ritonavir is missed patients should take the dose as soon as possible and then return to their normal schedule. However, if a dose is skipped the patient should not double the next dose.
• Continued ritonavir therapy at a dose of 600 mg twice daily following loss of viral suppression may increase the likelihood of cross-resistance to other protease inhibitors.
• Ritonavir is not a cure for HIV-1 infection and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Patients should remain under the care of a physician when using ritonavir.
Drug Interactions
• Ritonavir may interact with some drugs; therefore, patients should be advised to report to their doctor the use of any other prescription, non- prescription medication or herbal products, particularly St. John's Wort.
• Instruct patients receiving combined hormonal contraception to use an effective alternative contraceptive method or an additional barrier method during therapy with ritonavir because hormonal levels may decrease [see Drug Interactions ( 7.2), Use in Specific Populations ( 8.3)].
Hepatotoxicity
Pre-existing liver disease including Hepatitis B or C can worsen with use of ritonavir. This can be seen as worsening of transaminase elevations or hepatic decompensation. Advise patients that their liver function tests will need to be monitored closely especially during the first several months of ritonavir treatment and that they should notify their healthcare provider if they develop the signs and symptoms of worsening liver disease including loss of appetite, abdominal pain, jaundice, and itchy skin [see Warnings and Precautions ( 5.3)].
Pancreatitis
Pancreatitis, including some fatalities, has been observed in patients receiving ritonavir therapy. Advise patients to notify their healthcare provider of signs and symptoms (nausea, vomiting, and abdominal pain) that might be suggestive of pancreatitis [see Warnings and Precautions ( 5.4)].
Allergic Reactions/Hypersensitivity
Skin rashes ranging in severity from mild to Stevens-Johnson syndrome have been reported in patients receiving ritonavir. Advise patients to contact their healthcare provider if they develop a rash while taking ritonavir [see Warnings and Precautions ( 5.5)].
PR Interval Prolongation
Ritonavir may produce changes in the electrocardiogram (e.g., PR prolongation). Advise patients to consult their healthcare provider if they experience symptoms such as dizziness, lightheadedness, abnormal heart rhythm or loss of consciousness [see Warnings and Precautions (5.6)].
Lipid Disorders
Advise patients that treatment with ritonavir therapy can result in substantial increases in the concentration of total cholesterol and triglycerides [see Warnings and Precautions ( 5.7)].
Diabetes Mellitus/Hyperglycemia
Advise patients that new onset of diabetes or exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported and to notify their healthcare provider if they develop the signs and symptoms of diabetes mellitus including frequent urination, excessive thirst, extreme hunger or unusual weight loss and/or an increased blood sugar while on ritonavir as they may require a change in their diabetes treatment or new treatment [see Warnings and Precautions ( 5.8)].
Immune Reconstitution Syndrome
Advise patients that immune reconstitution syndrome has been reported in HIV- infected patients treated with combination antiretroviral therapy, including ritonavir [see Warnings and Precautions ( 5.9)].
Fat Redistribution
Advise patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long term health effects of these conditions are not known at this time [see Warnings and Precautions ( 5.10)].
Patients with Hemophilia
Advise patients with hemophilia that they may experience increased bleeding when treated with protease inhibitors such as ritonavir [see Warnings and Precautions ( 5.11)].
Ritonavir Oral Solution Not Recommended During Pregnancy
Advise pregnant women that use of ritonavir oral solution during pregnancy is not recommended due to its alcohol content [see Dosage and Administration ( 2.3) and Use in Specific Population ( 8.1)].
Pregnancy Exposure Registry
Inform patients that there is an antiretroviral pregnancy registry that monitors fetal outcomes of pregnant women exposed to ritonavir [see Use in Specific Populations ( 8.1)].
Lactation
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations ( 8.2)].

Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854

By:HETERO****TM
Hetero Labs Limited
Jeedimetla,

Hyderabad -500 055,

India
Revised: 02/2023