Pacnogen can cause two serious problems that your healthcare team will watch for closely:

• Severe allergic (hypersensitivity) reactions. Pacnogen can cause serious allergic reactions that may be life-threatening and, in rare cases, fatal. These usually happen during or soon after the infusion. To lower this risk, you will be given other medicines before each dose of Pacnogen (premedication), and will be observed closely during the infusion. Tell your healthcare provider or nurse right away if you notice trouble breathing, chest tightness, dizziness or faintness, flushing, swelling of the face or throat, hives, or an itchy rash during or after your infusion.
• Low blood cell counts. Pacnogen can lower your blood cells, especially the white blood cells (neutrophils) that fight infection. This can make serious infections more likely, and can also cause tiredness (from low red cells) or bleeding and bruising (from low platelets). Your doctor will check your blood counts before each dose and may delay your treatment or lower your dose if your counts are too low. Tell your doctor right away about a fever (temperature above 100.4°F / 38°C), chills, or other signs of infection.

Before receiving Pacnogen, tell your doctor about all of your previous and existing medical conditions and all the medicines you take, including if you:

• Have ever had an allergic reaction to paclitaxel, or to a medicine that contains polyoxyl castor oil (also called Cremophor) — you may not be able to receive Pacnogen;
• Have liver problems;
• Have heart problems, including problems with your heartbeat or heart rhythm;
• Have numbness, tingling, or burning in your hands or feet (neuropathy);
• Have an infection, or have low blood cell counts;
• Are pregnant, could become pregnant, or think you may be pregnant — Pacnogen must not be used during pregnancy, as it can harm your unborn baby. If you are a woman who can become pregnant, avoid becoming pregnant and use effective birth control (contraception) during treatment, and tell your doctor right away if you become pregnant;
• Are breastfeeding — do not breastfeed during treatment with Pacnogen;
• Are planning to have children in the future — Pacnogen may affect fertility, so discuss this with your doctor before starting treatment;
• Have liver problems, epilepsy, or a history of alcohol dependence — each dose of Pacnogen contains a small amount of alcohol.

Also tell your doctor about all prescription and non-prescription medicines, vitamins, and herbal supplements you take.

• Pacnogen is given as an infusion into a vein (intravenous, or IV) by your healthcare provider, usually in a hospital or clinic.
• Before each dose, you will be given other medicines (premedication) to lower the risk of an allergic reaction.
• Your care team will check your blood counts before each dose, and will watch you closely during the infusion, including your blood pressure, heartbeat, and breathing.
• Your doctor will decide how much Pacnogen you receive and how often, based on your condition, your blood counts, and how you tolerate treatment. Your dose may be delayed, reduced, or stopped if you have side effects.

Serious side effects

Pacnogen can cause serious side effects, some of which can be life-threatening. Tell your doctor right away or get emergency medical help if you have any of the following:

• Severe allergic (hypersensitivity) reactions.Tell your health care team right away about trouble breathing, chest tightness, dizziness or faintness, flushing, swelling of the face or throat, hives, or a rash during or after your infusion.
• Low blood cell counts (especially white cells and platelets).Low white cells raise your risk of infection, and low platelets can cause bleeding or bruising. Tell your doctor about fever (above 100.4°F / 38°C), chills, unusual tiredness, or easy bruising or bleeding.
• Serious infections. Because Pacnogen can lower your white blood cells, infections can become serious or life-threatening. Tell your doctor about fever, chills, a cough, or pain when passing urine.
• Heart and blood pressure problems. Pacnogen can cause a slow, fast, or irregular heartbeat, changes in your heart's electrical activity, or low blood pressure especially during the infusion. Tell your healthcare provider if you feel faint or dizzy, or notice a fast, slow, or irregular heartbeat.
• Nerve problems (peripheral neuropathy). Numbness, tingling, burning, or pain in your hands or feet, which can sometimes be severe. Tell your doctor if this starts or gets worse.
• Injection site reactions. Redness, swelling, tenderness, or skin changes where the medicine goes in. Tell your nurse right away if you feel burning or pain during the infusion, because the medicine can damage the surrounding tissue if it leaks out of the vein.
• Severe diarrhea, or severe stomach (abdomen) pain. Tell your doctor right away.
• Mouth and lip sores (mucositis). These can make eating and drinking difficult. Tell your doctor if they are severe.
• Liver problems. Your doctor may check your liver with blood tests during treatment.
• Harm to an unborn baby. Pacnogen can harm an unborn baby. See the pregnancy information above.

Common side effects

These may include:

• hair loss
• low red blood cell count (anemia), which can cause tiredness
• numbness, tingling, or burning in your hands or feet (neuropathy)
• joint and muscle pain
• nausea and vomiting
• diarrhea
• mouth or lip sores (mucositis)
• mild allergic reactions, such as flushing or a rash
• swelling of your hands, face, or feet

This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

For further information

This page answers common questions about Pacnogen. It is for general information only and does not replace advice from your doctor or the full prescribing information. For complete details, including all warnings, precautions, and side effects, please read the Pacnogen prescribing information.