What type of drug is STRENSIQ?
STRENSIQ® (asfotase alfa) is the first and only prescription medicine used to treat people with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). It can be difficult to recognize HPP symptoms and how they relate to each other. When talking about them with a doctor, you may not know where to begin.
How is hypophosphatasia treated?
Treatment and Medication Options for Hypophosphatasia
These treatments include: Nonsteroidal anti-inflammatory drugs (NSAIDs) to treat bone and joint pain. Vitamin B6 to help to control seizures in severely affected infants. Regular dental care beginning early on.
What is the cost of STRENSIQ?
Strensiq prices without insurance will vary by retailer. As a guide, Strensiq subcutaneous solution (18 mg/0.45 mL) will typically cost around $16,000 for 5.5 milliliters.
What countries is STRENSIQ available?
STRENSIQ is approved in the United States, European Union, Japan, Canada, and other countries. STRENSIQ is the first therapy indicated in patients with perinatal/infantile- and juvenile-onset HPP to treat the underlying cause of HPP—deficient TNSALP.
How long do you take STRENSIQ?
STRENSIQ IMPROVES SKELETAL HEALING
- Study 1. 90% 90% AFTER 6 MONTHS OF STRENSIQ. treatment achieved complete or substantial bone healing.
- Study 2. 63% 63% AFTER 6 MONTHS OF STRENSIQ.
- 69% 69% AFTER 6 MONTHS OF STRENSIQ. treatment achieved complete or substantial bone healing.
Is there a generic for STRENSIQ?
Generic Name & Formulations:
Asfotase alfa 18mg/0.45mL, 28mg/0.7mL, 40mg/mL, 80mg/0.8mL; soln for SC inj; preservative-free.
What are symptoms of hypophosphatasia?
Symptoms
- Bowed (curved) arms and legs.
- Short stature.
- In babies, failure to grow or gain weight as they should.
- Fused skull bones.
- Soft, weak, or deformed bones, also called rickets.
- Wider than normal wrist and ankle bones.
- Breathing issues due to problems with chest and rib bones.
- Painful bones and joints.
Is hypophosphatasia a progressive disease?
Hypophosphatasia (HPP) is a chronic, progressive bone mineralization disorder caused by loss-of-function variants in the ALPL gene encoding the tissue-nonspecific isoenzyme of alkaline phosphatase (TNSALP).
Does insurance cover STRENSIQ?
Cigna covers asfotase alfa products (Strensiq®) as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence: Prior Authorization is recommended for prescription benefit coverage of Strensiq.
How do I travel with STRENSIQ?
Keep cool. To maintain its ideal temperature, STRENSIQ may be stored in an insulated cooler with ice or an ice pack. If traveling long distances by plane, call ahead to your airline to find out if refrigeration is provided in-flight or if attendants can provide additional ice.
How is STRENSIQ made?
STRENSIQ is a tissue nonspecific alkaline phosphatase produced by recombinant DNA technology in a Chinese hamster ovary cell line. TNSALP is a metallo-enzyme that catalyzes the hydrolysis of phosphomonoesters with release of inorganic phosphate and alcohol.
When was STRENSIQ FDA approved?
Development timeline for Strensiq
| Date | Article |
|---|---|
| Oct 23, 2015 | Approval FDA Approves Strensiq (asfotase alfa) for Perinatal, Infantile and Juvenile-Onset Hypophosphatasia |
| Dec 30, 2014 | Alexion Completes Rolling BLA Submission to FDA for Asfotase Alfa for Hypophosphatasia |
What deficiencies cause low alkaline phosphatase?
Magnesium deficiency can lower alkaline phosphatase activity levels in the body because The enzyme needs magnesium to activate.
How does hypophosphatasia affect the body?
General Discussion. Hypophosphatasia (HPP) is a rare genetic disorder characterized by impaired mineralization (“calcification”) of bones and teeth. Problems occur because mineralization is the process by which bones and teeth take up calcium and phosphorus required for proper hardness and strength.
Is hypophosphatasia a disability?
Hypophosphatasia (perinatal and infantile onset types) automatically qualifies you for social security disability benefits under the Social Security Administration’s guidelines.
How long do you take Strensiq?
What is juvenile onset hypophosphatasia?
Childhood hypophosphatasia, defined as onset of symptoms between six months and eighteen years, can manifest as rickets, pain, decreased mobility, deficits of growth, and fractures. Historical treatment has generally involved a combination of dietary and rehabilitative interventions.
Is low alkaline phosphatase serious?
Low levels
Having lower-than-normal ALP levels in your blood can indicate a protein deficiency or Wilson’s disease. It may also signal malnutrition, which could be caused by celiac disease or an insufficient amount of certain vitamins and minerals. Low ALP can also indicate a rare condition called hypophosphatemia.
What should I do if my alkaline phosphatase is low?
If your alkaline phosphatase is low, you need to seek medical attention for an underlying condition. People with low alkaline phosphatase due to genetic disorders or serious medical conditions need to receive a treatment plan from their healthcare provider.
What does hypophosphatasia feel like?
hypo-fahs-fuh-TAY-shuh
HPP is a rare condition that can look and feel like many things: fatigue, pain, broken bones. While these symptoms may seem disconnected, HPP could be behind them all. It can also mirror symptoms found in other more common conditions like osteoporosis, osteopenia, and fibromyalgia.
How do I know if I have hypophosphatasia?
Adult forms of hypophosphatasia are characterized by a softening of the bones known as osteomalacia. In adults, recurrent fractures in the foot and thigh bones can lead to chronic pain. Affected adults may lose their secondary (adult) teeth prematurely and are at increased risk for joint pain and inflammation.
How do you fix low alkaline phosphatase?
Low alkaline phosphatase is a rare finding on a blood test. It usually results from some sort of malnutrition and is treated by correcting the underlying nutritive cause. Supplements for protein, B vitamins, vitamin C and thyroid hormones are the usual treatment for a low alkaline phosphatase.
What causes low levels of alkaline phosphatase?
Low levels of ALP are less common. They may be a sign of a lack of zinc, malnutrition, pernicious anemia, thyroid disease, Wilson disease or hypophosphatasia, a rare genetic disease that affects bones and teeth. Learn more about laboratory tests, reference ranges, and understanding results.
Which of the following are clinical signs of hypophosphatasia?
Table 3
| Clinical form (age at onset) | Perinatal (birth – 4 weeks) |
|---|---|
| Clinical signs and symptoms | ✓ defective skeletal mineralization ✓ chest deformities ✓ severe respiratory insufficiency ✓ respiratory complications ✓ seizures (Vit. B6 responsive) ✓ fractures ✓ deformities of long bones ✓ death |