Abraxane Uses, Dosage, Side Effects, Precautions & Warnings

Generic drug of the Therapeutic class: Oncology and hematology
Active ingredients: Paclitaxel

what is abraxane?

• Paclitaxel inhibits cancer (cytostatic).
• In cancer, such as ovaries, breasts, lung and skin.
• You get the infusion in the hospital, usually once every 2, 3 or 4 weeks.
• Side effects the first days: nausea, vomiting, diarrhea and less appetite.
• Within a few days to weeks: muscle pain, numbness or tingling sensation.
• Within a few weeks: anemia, bleeding, hair loss, sore mouth and throat. You are also more likely to have infections.
• Ask for advice about what you can do against the side effects. Hairs will grow again about a month after the treatment.
• You may not become pregnant during and for 6 months after treatment.

what is abraxane used to treat and indication?

• Abraxane is indicated as monotherapy in the treatment of metastatic breast cancer, in adult patients who have failed first-line treatment of metastatic cancer, and for whom standard treatment including an anthracycline is not indicated. precautions for use ).
• Abraxane in combination with gemcitabine is indicated for the first line treatment of adenocarcinoma of the metastatic pancreas in adult patients.
• Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and / or radiotherapy.

abraxane dosage

Abraxane should only be administered under the responsibility of a qualified oncologist in a unit specializing in the administration of cytotoxic agents.

 It must not replace or be substituted by other formulations of paclitaxel.

Dosage

Breast cancer

• The recommended dose of Abraxane is 260 mg / m ² administered as an intravenous infusion for 30 minutes every 3 weeks.

Dose adjustments during breast cancer treatment

• Patients with severe neutropenia (neutrophil count <500 / mm ³ for at least 1 week) or severe sensory neuropathy during treatment with Abraxane should receive a reduced dose of 220 mg / m ² for further treatment. . Following the recurrence of severe neutropenia or severe sensory neuropathy, the dose will again be reduced to 180 mg / m ² .
•  Abraxane should not be administered until neutrophil counts recover to> 1500 / mm ³. For Grade 3 sensory neuropathies, treatment will be suspended until neuropathy regresses to grade 1 or 2, and the dose administered will be reduced for all subsequent courses.

Adenocarcinoma of the pancreas

• The recommended dose of Abraxane in combination with gemcitabine is 125 mg / m ²given as a 30-minute intravenous infusion on days 1, 8 and 15 of each 28-day cycle. 
• The recommended concomitant dose of gemcitabine is 1000 mg / m ² intravenously infused 30 minutes immediately following the completion of Abraxane on days 1, 8 and 15 of each 28-day cycle.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in the Composition section .
• Breast-feeding (see section Pregnancy and breast-feeding ).
• Patients with a pre-treatment neutrophil count <1,500 / mm ³ . 

What are the side effects of Abraxane?

This medicine has a powerful effect on cell division, not only of cancer cells but also of healthy body cells. This may cause side effects, for example in places where the cells naturally naturally divide. These are the mucous membranes of the mouth, stomach and intestines, the skin, the hair and the blood.

Because of the list of side effects, it can seem that the medicine is worse than the disease. But the side effects do not occur to everyone to the same extent. Moreover, the side effects after the chemotherapy gradually over.

The main side effects are the following.

Regularly (with more than 30 in 100 people)

• Anemia, an increased risk of infections and an increased risk of bleeding, such as bloody noses. These side effects occur because the body produces fewer red and white blood cells and fewer platelets. Sometimes it is necessary to reduce the dose or to postpone the next administration. Sometimes medicines are possible to stimulate the production of blood cells. The doctor will therefore regularly have your blood checked during treatment. The blood will recover when the cure has ended.
  Contact your doctor during the following symptoms: unexplained fever or sore throat, blisters in the mouth and throat, nosebleeds, unexplained bruises and extreme tiredness.
  Due to the shortage of white blood cells, you are also more susceptible to infections caused by viruses, bacteria or fungi. Always contact your doctor in case of infections such as cold, strep throat, flu, boils and other skin infections.
• Hair loss and baldness. Not only of hair, but also of eyebrows, eyelashes, armpit and pubic hair. After the treatment, the hair will start to grow again after about a month.
• Gastrointestinal complaints such as nausea, vomiting, loss of appetite and diarrhea. Rarely abdominal pain and constipation. These side effects are caused by inflammation of the mucous membranes of esophagus, stomach and intestines. The symptoms usually begin on the first day of treatment and can last for several days.
  Very rarely diarrhea is caused by inflammation of the last part of the intestine.
  To combat stomach pain and heartburn, the doctor may prescribe a stomach protection agent. In case of nausea, the doctor prescribes an antiemetic agent. Sometimes it helps to eat more often, but then little bits.
  Make sure you drink extra if you have diarrhea and have to vomit. Contact your doctor if you have loose stools four times or more per day on top of your normal bowel pattern or if you also have diarrhea at night. Sometimes it is necessary to prevent dehydration with medication against diarrhea or a fluid infusion. You should also warn the doctor if you need to vomit more than once a day.
• Painful mouth, tongue or throat, dry mouth, taste disturbances. These side effects are caused by inflammation of the mucous membranes of the mouth, throat and esophagus. You can see this by a fiery red color of the mucous membranes. Eating and drinking can be painful because of this. In many cases it helps to suck on ice cubes, during and immediately after chemotherapy.
  During the chemotherapy, surgery on your teeth or in your mouth can make the symptoms worse. Before you start the chemotherapy, it is therefore wise to have your dentist check your teeth and treat them if necessary. Treat your teeth extra well by brushing a few times a day with a soft toothbrush. You can also rinse with a disinfectant mouthwash.
• Weakness , back pain , muscle pain , leg cramps, rarely joint pain.
• Nerve damage. You will notice a deaf or tingling sensation in the arms or legs, very rarely from severe pain in the arms or legs. Very rarely your hearing nerve can get damaged. Consult your doctor if you hear less well, get tinnitus, are spinning or get pain in arms or legs.

Sometimes (from 10 to 30 people in 100)

• Insomnia, drowsiness, headache .
• Psychological complaints such as depression, confusion, difficulty with clear thinking.
• Hold moisture (edema). You notice that swelling of feet and ankles. You can also retain moisture in the lungs. You notice that there is trouble, breathe and cough . Your weight can also increase. Because you retain fluid, your blood pressure can rise. Very rarely you can suffer from heart failure , cardiac arrhythmia or chest pain . Your doctor will check your heart function regularly before, during and after treatment. In some cases, the doctor prescribes the adrenal hormone dexamethasone to reduce the risk of fluid retention.
• Skin rash, dry skin, acne, red skin and itching. Skin rash can also indicate hypersensitivity (see Rare: Hypersensitivity ).
• Reduced fertility. 
  In women , the sex hormones can be disturbed, causing menstruation to stay away for some time and later become less likely to get pregnant. Women can get into the transition earlier by using this medicine.
  In some men , the formation of sperm cells can stop, making them permanently infertile. Discuss with your doctor the possibility to store sperm cells before you start the treatment.
• Hypersensitivity to this medication. This sometimes arises a few minutes after the start of the infusion. You notice this flushing, skin rash or itching. Rarely, severe sensitization develops with chest tightness, chest pain, fever, chills, sweating, fainting or swelling of the face, mouth or tongue. Your doctor will monitor you well during the infusion.
  Very rarely, a severe skin condition develops with blisters, especially on the lips and on the mucous membranes of the mouth and genitals. Then immediately notify a doctor. Usually the doctor prescribes medication to reduce the risk of hypersensitivity, such as dexamethasone and diphenhydramine. If you receive a paclitaxel infusion with ‘nanoparticles’ (Abraxane), this side effect is very rare and it is usually not necessary to also use medicines to prevent hypersensitivity.

Rarely (from 1 to 10 in 100 people)

• Damage to the nails, discoloration or loosening of the nails. You can partially prevent this side effect by protecting hands and feet from sunlight.
• Pain or tingling sensation on and around the site of the infusion needle. This can occur because the infusion fluid ends up in the surrounding tissue outside the vein. This allows the tissue to become seriously inflamed and start to swear. Tell your doctor or nurse immediately if you have symptoms such as redness, heat and swelling.
• Gastrointestinal bleeding. Warn a doctor if you notice a black tarry stool. This can indicate blood in the stool.
• Fever, chills, muscle pain and a flu feeling. Contact your doctor or nurse at temperatures above 38.5 ºC.
• Difficulty in urinating, pain when urinating.
• Movement disorders , such as difficulty or slow walking, swinging.

Very rare (affects less than 1 in 100 people)

• Dry eyes, irritation of the eyes, blurred vision. Very rarely, a serious side effect develops which reduces your vision. Warn your doctor if you see less well.
• Damage to the liver, pancreas, kidneys or lungs. Your doctor will regularly check the functioning of liver, kidneys and lungs.

Contact your nurse or doctor if you suffer too much from any of the side effects mentioned above. Sometimes it is necessary to adjust the dosage so that the side effects decrease. Sometimes the doctor will prescribe another medication against the side effects.

Also discuss with your doctor or nurse if you are concerned about side effects. Do you experience any other side effects than those listed above? Report this to your pharmacy, doctor or nurse.

Caution

• This medication is harmful to the unborn child. Women should not become pregnant if they use this medicine. Even men who use this medicine should not make their partner pregnant.
• Both men and women must therefore use good contraception . Go with the contraception until at least 6 months after the chemotherapy. Discuss this with your doctor.

abraxane drug interactions

• Paclitaxel is partially metabolized by the cytochrome P450, CYP2C8 and CYP3A4 isoenzymes (see section 5.2 ). Therefore, in the absence of a pharmacokinetic drug interaction study, caution should be exercised when paclitaxel is administered concomitantly with inhibitory drugs (ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir and nelfinavir) or inducers (rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) of CYP2C8 or CYP3A4.
• Paclitaxel and gemcitabine do not have a common metabolic pathway. The clearance of paclitaxel is mainly due to metabolism by CYP2C8 and CYP3A4 followed by biliary excretion, while gemcitabine is inactivated by cytidine deaminase and then excreted renally. The pharmacokinetic interactions between Abraxane and gemcitabine have not been studied in humans.
• A pharmacokinetic study was conducted with Abraxane and carboplatin in patients with non-small cell lung cancer. Clinically relevant pharmacokinetic interactions between Abraxane and carboplatin have not been observed.
• Abraxane is indicated as monotherapy in the treatment of breast cancer, in combination with gemcitabine for the treatment of pancreatic adenocarcinoma or in combination with carboplatin for the treatment of non-small cell lung cancer (see section 4.4 ). Abraxane should not be used in combination with other anti-cancer agents.

Abraxane Warnings and Precautions

Abraxane is a formulation of nanoparticles of paclitaxel-albumin that may have pharmacological properties very different from other formulations of paclitaxel (see sections Pharmacodynamic properties and Pharmacokinetic properties ).

 Do not replace it with other paclitaxel formulations or use it in their place.

hypersensitivity

• Rare cases of severe hypersensitivity reactions, including very rare anaphylactic reactions of fatal outcome, have been reported.
•  In case of hypersensitivity reaction, this medicinal product should be stopped immediately, symptomatic treatment should be put in place and the patient should not be exposed to paclitaxel again.

Hematology

• Medullary aplasia (mainly neutropenia) is common with Abraxane. Neutropenia is dose-dependent and is a dose-limiting toxicity. It is necessary to closely monitor blood counts throughout treatment with Abraxane.
• It should resume treatment with Abraxane only if neutrophils recover to> 1500 / mm ³and platelets> 100,000 / mm ³ .

neuropathy

• Sensory neuropathies are common in Abraxane. However, severe symptoms develop more rarely. The occurrence of grade 1 or 2 sensory neuropathy usually does not require a dose reduction. 
• If Grade 3 sensory neuropathy develops during treatment with Abraxane monotherapy, treatment will be suspended until neuropathy regresses to grade 1 or 2, and it is recommended that the dose be reduced to all the following courses of Abraxane (see section Dosage and method of administration ).
•  If peripheral neuropathy ≥ grade occurs 3 during treatment with Abraxane in combination with gemcitabine, administration of Abraxane should be discontinued and treatment with gemcitabine continued at the same dose. 
• Treatment with Abraxane will be resumed at a reduced dose after resolution of peripheral neuropathy at grade 0 or 1 . If a ≥3-grade peripheral neuropathy occurs during treatment with Abraxane in combination with carboplatin, treatment should be discontinued until the regression of neuropathy to grade 0 or 1, and will be resumed by reducing the dose for all subsequent courses of Abraxane and carboplatin .

septicemia

• Sepsis has been reported with an incidence of 5% in patients with and without neutropenia who received the combination Abraxane – gemcitabine. Complications related to underlying pancreatic cancer, particularly biliary obstruction or the presence of a biliary stent, have been identified as significant contributing factors.
•  If a patient develops fever (regardless of neutrophil count), broad-spectrum antibiotic therapy should be initiated. 
• In case of febrile neutropenia, the administration of Abraxane and gemcitabine should be suspended until the fever is gone and the neutrophil count is ≥ 1,500 / mm ³ ). , then treatment will be resumed at reduced doses ( see section Dosage and method of

pneumonia

• Pneumonia occurred in 1% of patients receiving Abraxane monotherapy and in 4% of patients receiving Abraxane in combination with gemcitabine. All patients should be closely monitored for signs or symptoms of pneumonia. 
• If pneumonia is diagnosed and infectious aetiology is excluded, treatment with Abraxane and gemcitabine should be discontinued and appropriate treatment and supportive measures should be initiated promptly  .

Hepatic insufficiency

• Since paclitaxel toxicity may be increased in patients with hepatic impairment, caution should be exercised when administering Abraxane to patients with hepatic impairment. Patients with hepatic impairment have an increased risk of toxicity, particularly in terms of myelosuppression ; these patients should be closely monitored for the risk of severe myelosuppression.
• Abraxane is not recommended for patients with total bilirubin> 5 x LNS or ASAT> 10 x LNS. In addition, Abraxane is not recommended in patients with metastatic pancreatic adenocarcinoma with moderate to severe hepatic impairment (total bilirubin> 1.5x LNS and ASAT ≤ 10x LNS).

cardiotoxicity

• Rare cases of congestive heart failure and left ventricular dysfunction have been observed in individuals receiving Abraxane. Most of them had been previously exposed to cardiotoxic drugs, such as anthracyclines, or had underlying cardiac pathology. Therefore, patients receiving Abraxane should be  closely monitored by their physician for the risk of experiencing cardiac events.

Metastases of the central nervous system

• The efficacy and safety of Abraxane in patients with metastases in the central nervous system (CNS) have not been established. CNS metastases are generally poorly controlled by systemic chemotherapy.

Gastrointestinal symptoms

• If patients experience nausea, vomiting and diarrhea following Abraxane administration, they may be treated with common antiemetic and antidiarrheal agents.

Patients aged 75 and over

In patients aged 75 years and older, there has been no evidence of benefit from Abraxane in combination with gemcitabine versus gemcitabine monotherapy. In very elderly patients ( ≥75 years) who received Abraxane and gemcitabine, there was a higher incidence of serious adverse events and adverse events leading to discontinuation of treatment, including hematologic toxicities, peripheral neuropathy, decreased appetite and dehydration. The ability to tolerate Abraxane in combination with gemcitabine should be carefully evaluated in patients with pancreatic adenocarcinoma aged 75 years and older, with particular reference to performance index, comorbidities, and increased risk of Dosage and Method of Administration and Adverse Effects ).

Other

• Although the available data are limited, no clear benefit has been demonstrated in terms of increased overall survival in patients with pancreatic adenocarcinoma with a normal CA 19-9 before the onset of treatment with Abraxane plus gemcitabine (  Pharmacodynamic properties ).
• Erlotinib should not be coadministered with Abraxane in combination with gemcitabine (see section 4.5. Interactions with other medicinal products and other forms of interaction).

excipients

• After reconstitution, each ml of Abraxane suspension contains 0.183 mmol of sodium, ie 4.2 mg of sodium. To be considered in patients controlling their dietary sodium intake.

Drive and use machines

Abraxane has minor to moderate influence on the ability to drive and use machines.

Abraxane can cause side effects such as fatigue (very common) and dizziness (frequent) that can affect the ability to drive and use machines.

Patients should be advised not to drive or operate machinery if they feel tired or dizzy.

Abraxane and PREGNANCY / BREAST FEEDING / FERTILITY

Contraception in men and women

Women of childbearing potential must use an effective method of contraception during treatment with Abraxane and up to 1 month after stopping treatment. Men treated with Abraxane should not conceive for the duration of treatment and up to six months after stopping treatment.

Pregnancy

Breastfeeding

Fertility

• Abraxane is responsible for sterility in male rats ( see Preclinical Safety ).
•  Before starting treatment with Abraxane, male patients are advised to learn about sperm preservation procedures because of the potential risk of treatment-related irreversible sterility.

What should I do if I miss a dose?

Did you forget the appointment? 

Then immediately contact the hospital to make a new appointment.

What happens if I overdose from Abraxane ?

• There is no known antidote for overdose of paclitaxel. In case of overdose, the patient should be closely monitored.
• Treatment should focus on the main foreseeable complications of overdose such as myelosuppression, peripheral neuropathies and mucositis.

What is  Forms and Composition?

• Powder for suspension for injection for infusion at 5 mg / mL (in albumin-bound nanoparticle formulation, yellow-white):   vials of 100 mg or 250 mg ^* , single unit.

NOT’s

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