Aralast NP is administered as an intravenous (IV) infusion. A healthcare professional will prepare the medication to ensure it is mixed and diluted appropriately before injection.

Preparation: The Aralast NP vial is reconstituted with sterile water, and the solution is then prepared for infusion.

Administration: Aralast NP is typically administered once a week. The patient will receive the infusion in a clinical setting or at home if the healthcare provider approves home infusion.

Monitoring: The patient will be monitored for immediate allergic reactions and side effects during infusion. Infusions are relatively tolerated; however, in some cases, patients do report symptoms of fever and chills.

Patients should adhere to the prescribed regimen and regularly come for follow-up to ensure that the drug is not causing any adverse reactions. The infusion schedule or the dose can be altered depending on the patient’s response and any side effects he or she may experience.

Aralast NP works by replacing the deficient alpha-1 antitrypsin protein in AATD patients. This protein produced by the liver is transported into the blood stream wherein it exerts its action. In the healthy organism, alpha-1 antitrypsin prevents the action of enzymes, for instance, neutrophil elastase, from causing any damage to lung tissue.

In individuals with AATD, neutrophil elastase does not have sufficient alpha-1 antitrypsin to inhibit it properly. This results in an unchecked neutrophil elastase that destroys lung tissue and leads to emphysema or other types of lung diseases. Since this drug delivers a purified version of this protein, Aralast NP prevents further deterioration of the lungs, slow the progression of emphysema, and hence decrease the use of supplementary treatment, such as bronchodilators or inhaled steroids.

The protein provided by Aralast NP also reduces inflammation and can have a protective effect on the liver, which is particularly important for individuals who are at risk of liver disease due to AATD.

Common side effects of Aralast NP may include:

Infusion-related reactions: These involve fever, chills, rash, and nausea, which usually resolve after infusions are completed. Such patients may need medical evaluation if the reaction is particularly severe.

Allergic reaction: This is a rather rare occurrence but can develop as hives, shortness of breath, or swelling for some patients. Such symptoms should be evaluated immediately to avoid further complications.

Other side effects: Some patients may suffer from joint pains, fatigue, or even mild respiratory symptoms. The side effects are usually mild and temporary.

Serious side effects are rare and include:

Anaphylactic reaction: This is a severe allergic reaction that requires immediate medical attention.

Hepatic complications: Although this is rare, some patients may suffer from liver problems due to the infusion therapy.

Allergic Reactions: Patients have to be kept under a close watch for any symptoms of allergic reaction to the Aralast NP through and after infusion. Special care may have to be taken for the patient that has had some history of severe allergic reaction to an intravenous therapy.

Infusion Reactions: Health care should keep the patient under regular observation while infusion is made. Some infusion reactions experienced are fever, chills, or even hives, though it is minimal.

Liver Disease: Patients with existing liver conditions should be closely monitored, as alpha-1 antitrypsin deficiency itself can cause liver damage, and Aralast NP may exacerbate this in some individuals.

Pregnancy and Breastfeeding: The safety of Aralast NP during pregnancy and breastfeeding has not been fully established. It is important for pregnant or breastfeeding women to discuss the risks and benefits with their healthcare provider before starting treatment.

Since Aralast NP is a replacement therapy for a protein in the body, it is unlikely to interact with most drugs. However, as with any infusion therapy, patients receiving Aralast NP should be monitored for potential allergic reactions or infusion-related side effects.

There are no known major drug-drug interactions with Aralast NP; however, all medications the patient is taking should be brought to the attention of the healthcare provider, including over-the-counter drugs and supplements.

The standard dose of Aralast NP is based on the patient’s weight. The average dose is 60 mg/kg body weight, and it is administered once a week via intravenous infusion. The healthcare provider can adjust the dosing regimen based on the clinical response of the patient and side effects experienced. Follow-up visits are necessary to monitor the condition of the patient and see if changes are required.

Aralast NP can only be prescribed, thus a healthcare provider should possess experience in the treatment and management of alpha-1 antitrypsin deficiency. A health professional will assess the clinical status of the patient to know the appropriate dosing regimen. Patients on Aralast NP will also require constant assessment and follow-up appointments so that the effectiveness of their treatment and any possible adverse effects can be reviewed.

1. What is Aralast NP?

   • Answer: Aralast NP is a therapeutic protein replacement therapy that contains purified alpha-1 antitrypsin (AAT), which is used to treat individuals diagnosed with Alpha-1 Antitrypsin Deficiency.

2. How does Aralast NP work?

   • Answer: Aralast NP works by supplementing the deficiency of alpha-1 antitrypsin in the body, which helps protect the lungs and liver from damage caused by enzymes such as neutrophil elastase.

3. What conditions is Aralast NP used to treat?

   • Answer: Aralast NP is primarily used to treat Alpha-1 Antitrypsin Deficiency (AAT deficiency), particularly to manage lung disease associated with this condition.

4. Who is a candidate for Aralast NP treatment?

   • Answer: Individuals diagnosed with AAT deficiency, particularly those who exhibit symptoms of lung disease (like emphysema), may be candidates for treatment with Aralast NP.

5. How is Aralast NP administered?

   • Answer: Aralast NP is administered via intravenous (IV) infusion. The dosage and frequency depend on the specific needs of the patient and are determined by a healthcare professional.

6. What are the common side effects of Aralast NP?

   • Answer: Common side effects include headache, fatigue, nausea, fever, and infusion-related reactions such as chills or itching at the injection site.

7. Are there any serious risks associated with Aralast NP?

   • Answer: Serious risks may include allergic reactions, severe skin reactions, or the transmission of infectious agents due to the product being derived from human plasma. Patients should report any unusual symptoms to their doctor immediately.

8. Can Aralast NP be used during pregnancy?

   • Answer: Pregnancy categories for drugs can vary, so it’s essential for pregnant women to discuss the benefits and risks of Aralast NP with their healthcare provider.

9. How often do patients need to receive Aralast NP?

   • Answer: Treatment frequency typically ranges from weekly to bi-weekly infusions, depending on the patient’s needs and the doctor’s recommendations.

10. Is there any special monitoring required while on Aralast NP?

    • Answer: Patients receiving Aralast NP should have regular check-ups to monitor lung and liver function, as well as to check for any potential side effects of treatment.

11. Can Aralast NP be used in children?

    • Answer: The use of Aralast NP in pediatric patients is guided by a healthcare provider, and safety and effectiveness in children should be evaluated on an individual basis.

12. What should I do if I miss a dose of Aralast NP?

    • Answer: If a dose is missed, it should be administered as soon as possible, but patients should consult their healthcare provider to determine the appropriate course of action.

13. Can I take other medications while on Aralast NP?

    • Answer: Always inform your healthcare provider about all medications you are taking, as some drugs may interact with Aralast NP.

14. How should Aralast NP be stored?

    • Answer: Aralast NP should be stored in a refrigerator between 2°C to 8°C (36°F to 46°F) and should not be frozen. It must also be kept out of reach of children.

15. What happens if Aralast NP is not refrigerated?

    • Answer: If Aralast NP is exposed to room temperature for a short time, it can still be used, but any prolonged exposure should be confirmed with a healthcare provider before use.

16. What are the signs of an allergic reaction to Aralast NP?

    • Answer: Signs of an allergic reaction may include rash, itching, difficulty breathing, swelling of the face or throat, or dizziness. Emergency medical care should be sought if these symptoms occur.

17. Can Aralast NP be used long-term?

    • Answer: Many patients may need long-term treatment with Aralast NP; however, it is essential to have regular follow-ups with a healthcare provider to assess the continued need and any side effects.

18. What should I do if I experience an infusion reaction?

    • Answer: If an infusion-related reaction occurs during administration, the infusion should be slowed or stopped, and medical advice should be sought immediately.

19. Is there a risk of developing infections from Aralast NP?

    • Answer: While precautions are taken to reduce infection risk, there is still a small chance of transmitting viruses due to the human-derived nature of the product. Patients should be monitored for infections.

20. Where can I find more information about Aralast NP?

    • Answer: More information can be found on the official website of the manufacturer, through your healthcare provider, or in the product’s prescribing information literature.