What is it?

What is it?

Nowaria^® is the brand name of filgrastim and is supplied in 300 mcg /0.5 ml solution for injection in a pre-filled syringe. It is a Granulocyte Colony-Stimulating Factor (G-CSF) produced by recombinant DNA technology; which stimulates the production, maturation, and activation of neutrophils.

Indications

Nowaria^® is used to treat:

• Chemotherapy-induced myelosuppression in non-myeloid malignancies

• Acute myeloid leukemia following induction or consolidation chemotherapy

• Bone marrow transplantation

• Hematopoietic radiation injury syndrome, acute

• Peripheral blood progenitor cell collection and therapy

• Reducing the risk of infection  in patients with advanced HIV infection..

Contraindications

What should be considered BEFORE treatment?

·         Take special care with other products that stimulate white blood cells.

·         Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

·         If an individual is a stem cell donor, they must be between 16 and 60 years old.

·         In the case of severe chronic neutropenia, the risks of developing blood cancers should be considered, and the necessary tests should be conducted.

·         Nowaria^® may have a minor influence on your ability to drive and use machines.

·         Nowaria^® has not been tested in pregnant or breastfeeding women. Nowaria^® is not recommended during pregnancy. It is important to tell your doctor if you: are pregnant or breast-feeding; or think you may be pregnant; or are planning to have a baby. Unless your doctor directs you otherwise, you must stop breast-feeding if you use Nowaria^®.

·         If you (or your child) have Hereditary Fructose Intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine.

·         Do not use Nowaria^® if you are allergic to human granulocyte colony stimulating factors, such as filgrastim or any of the other ingredients of this medicine.

What should be considered DURING treatment?

•         Tell all of your healthcare providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.

•         Do not get this drug at the same time or within 24 hours before or after chemotherapy or radiation treatment. Talk with your doctor.

•         Have your blood work and other lab tests checked as you have been told by your doctor.

•         This drug may affect certain lab tests. Tell all of your healthcare providers and lab workers that you take this drug.

•         Some people with sickle cell disease have had times where the sickle cell disease has gotten worse when taking this drug. Talk with the doctor.

•         Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.

• If you experience a loss of response or failure to maintain a response with filgrastim treatment, your doctor will investigate the reasons why including whether you have developed antibodies which neutralize filgrastim’s activity.

·         Do not increase the dose your doctor has given you. If you think you have injected more than you should, contact your doctor as soon as possible.

·         If you have missed an injection, or injected too little, contact your doctor as soon as possible. Do not take a double dose to make up for any missed doses. If you have any further questions about the use of this medicine, ask your doctor, nurse or pharmacist.

How to Use?

How to Use?

·         Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure.

·         Nowaria^® is usually given as a daily injection into the tissue just under the skin (known as a subcutaneous injection). The usual dose varies depending on your illness and weight. Your doctor will tell you how much Nowaria^® you should take. You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home. However, you should not attempt this unless you have been properly trained first by your healthcare provider.

·         You will need to take Nowaria^® until your white blood cell count is normal. Regular blood tests will be taken to monitor the number of white blood cells in your body. Your doctor will tell you how long you will need to take Nowaria^®.

·         The best places to inject are the top of your thighs and the abdomen. If someone else is injecting you, they can also use the back of your arms. You may change the injection site if you notice the area is red or sore.

Side Effects

Side Effects

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

·         Very common side effects

Chest pain, Skin rash, Nausea, Thrombocytopenia, Increased serum alkaline phosphatase, Dizziness, fatigue, pain, Back pain, ostealgia, Cough, dyspnea, Fever

Storage

How to store Nowaria^®

·         Keep this medicine out of the sight and reach of children.

·         Store in a refrigerator (2-8°C). Prevent freezing, but in the event of unintended or accidental freezing, no damage will occur to the product.

·         Keep the syringes in the outer carton in order to protect from light.

·         Accidental freezing will not harm Nowaria^®.

·         Do not use this medicine after the expiry date which is stated on the syringe label and carton after EXP.

·         Do not use this medicine if you notice discolouration, cloudiness or particles, it should be a clear, colourless liquid.

·         Do not throw away any medicines via wastewater or household waste.

·         Ask your pharmacist how to throw away medicines that are no longer required. These measures will help protect the environment.

FAQs